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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-16-D-0024 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
Not provided
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Randomized, interventional trial of Emergency Department (ED) administration of DSUVIA (sufentanil) versus standard care pain management comparing pain treatment outcomes in injured patients with moderate to severe pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSUVIA (sufentanil) | Experimental | Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator |
|
| Standard Care | Active Comparator | Subjects will receive standard care pain management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil 30 MCG Sublingual Tablet | Drug | 30 microgram sublingual tablet administered using sublingual applicator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Verbally Administered Numeric Rating Scale (VNRS) | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) | 30 minutes after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Verbally Administered Numeric Rating Scale (VNRS) | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) | Every 30 min from 30 min post administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Sperry, MD | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39919020 | Derived | Guyette FX, Chaudhary P, Vincent LE, Love ET, Brubaker DP, Neal MD, Brown JB, Rixe J, Barton DJ, Yates A, Wisniewski SR, Sperry JL. A Randomized Controlled Trial of Sublingual Sufentanil in Early Management of Pain in Trauma. Anesth Analg. 2025 Jul 1;141(1):172-180. doi: 10.1213/ANE.0000000000007384. Epub 2025 Feb 7. |
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De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
Data will become available after publication of the primary manuscript
Requests for data will be submitted in writing and reviewed by the principal Investigator
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| ID | Title | Description |
|---|---|---|
| FG000 | DSUVIA (Sufentanil) | Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator Sufentanil 30 MCG Sublingual Tablet: 30 microgram sublingual tablet administered using sublingual applicator |
| FG001 | Standard Care | Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DSUVIA (Sufentanil) | Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator Sufentanil 30 MCG Sublingual Tablet: 30 microgram sublingual tablet administered using sublingual applicator |
| BG001 | Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Verbally Administered Numeric Rating Scale (VNRS) | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes after administration |
|
Adverse events were collected up to 120 minutes after administration of the study drug
Adverse events included hypoxia (SpO2 <90%) requiring supplemental oxygen, hypotension (SBP<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DSUVIA (Sufentanil) | Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator Sufentanil 30 MCG Sublingual Tablet: 30 microgram sublingual tablet administered using sublingual applicator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SpO2 <90% requiring treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SpO2<90 |
Our study is a first of its kind comparing sublingual sufentanil to standard care in trauma patients. The intervention could not be blinded which imparts bias. This study was conducted at two level 1 trauma centers in the city of Pittsburgh and while the population was typical of our region, it may not be broadly generalizable. We did not dictate the choice or dose of analgesic in the standard arm. There was missingness in the data and no primary outcome was recorded in 20 subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francis X Guyette | University of Pittsburgh | 412 651 1077 | guyettef@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2023 | Jan 14, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 18, 2023 | Feb 9, 2024 | ICF_000.pdf |
Not provided
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D000286 | Administration, Sublingual |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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| standard care pain treatment | Drug | standard care pain treatment given in Emergency Department |
|
| Patient Global Assessment (PGA) of Pain Control | An assessment of the patient's pain, made by the patient themselves, made at 30 minute intervals up to 120 min after the intervention, or until discharge, or administration of rescue medication | every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) |
| Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | time-weighted Summed Pain Intensity Difference (SPID) is a statistical measure that calculates the cumulative pain reduction over a period of time by summing up the differences between baseline pain and current pain at various time points. The range for the SPID is 0-100 per time point, A score of 0 indicates no pain, a score of 100 indicating the worst pain intensity difference. Some patients did not participate in the SPID due to discharge or requiring rescue narcotic administration. | every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) |
| Number of Participants Who Needed Rescue Narcotic Doses | Count of patients requiring additional pain medication after recieving the intervention (sufentanil) or the standard care control. | at 30 minutes following administration and during ED stay (up to 120 minutes) |
| Patient Cognitive Function as Assessed by Six Item Screener (SIS) | The Six Item Screener (SIS) is a simple assessment of cognitive impairment. It asks 6 questions, 3 based on recall and 3 based on orientation, each question is worth 1 point. The score can range between 0 and 6 correct answers. Higher numbers of correct answers indicated better outcomes (less cognitive impairment). Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. | at 30 minutes following administration |
| Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Acceptability of pain treatment to health care providers based on a subjective assessment of the patients facial expressions, behavior, physical presentation and reported pain level. Nurses caring for the participant following treatment with the study drug were asked to characterize their patients pain relief as Poor, Fair, Good or Excellent. | at 30 minutes following administration |
| Number of Participants With Hypoxia Needing Supplemental Oxygen | The number of patients with an SpO2 less than 90 percent receiving supplemental oxygen | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
| Number of Participants With Hypotension | systolic blood pressure less than 90mmHg | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
| Number of Participants With Nausea | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
| Number of Participants With Vomiting | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
| Number of Participants With Headache | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
| Number of Participants With Dizziness Requiring Treatment | Dizziness requiring treatment | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
| Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | The Number of participants that had a 10 point reduction in their VNRS @ 30min intervals to 120min | Time to a 10 point reduction in VNRS following administration of study drug. Participants were followed to 120 min or discharge in 30 min intervals |
| Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management | Need for advanced airway or bag valve mask ventilation | From drug administration up to 120 min following administration |
| Richmond Agitation-Sedation Scale (RASS) | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. | Assessed at 30 minutes after administration |
| Richmond Agitation-Sedation Scale (RASS) @ 60 Min | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. | RASS @ 60 min |
| Richmond Agitation-Sedation Scale (RASS) @ 90 Min | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. | RASS @ 90 minutes |
| Richmond Agitation-Sedation Scale (RASS) @ 120 Min | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. | RASS @ 120 min |
Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total Glascow Coma Scale | The scale is the Glasgow Coma Scale. The Total score (Range 3-15) is the sum of the Eye (Range 1-4) Verbal (Range 1-5) and Motor (Range 1-6) scores, higher numbers in the sub scale are better. GCS Total of 15 is the best outcome while GCS 3 is worst and unresponsive. All patients enrolled in the study had to be capable of informed consent and therefore all had a GCS of 15. | Mean | Standard Deviation | units on a scale |
|
| Injury Severity Score | The scale is the Injury Severity Score. The Total ISS score (Range 0-75) is the sum of the squares of the three worst Abbreviated Injury Scores (AIS) from six body regions: Head/Neck (Range 0-5) Face (Range 0-5) Chest (Range 0-5), Abdomen (Range 0-5), Extremity (Range 0-5) and External (Range 1-5) scores, higher numbers in the sub scale are associated with worse injury. An AIS score of 0 indicates no injury, a score of 5 indicates a critical injury. The ISS Total is associated with mortality risk. | Median | Inter-Quartile Range | units on a scale |
|
| Injury Type | Count of Participants | Participants |
|
| Verbal Numerical Rating Scale @ 0 min | The scale Verbal Numerical Rating Scale (VNRS). The VNRS score (Range 0-100) is the patients assessment of their pain on a scale of 0 (no pain) to 100 (the most pain imaginable). | Mean | Standard Deviation | units on a scale |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Heart Rate | Mean | Standard Deviation | beats per minute |
|
|
|
|
| Secondary | Verbally Administered Numeric Rating Scale (VNRS) | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) | The number of patients analyzed at subsequent time points decreases as patients received rescue medications or left the Emergency Department (for admission, operative intervention, or discharge) prior to the 2 hr follow up period. | Posted | Mean | Standard Deviation | units on a scale | Every 30 min from 30 min post administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first |
|
|
|
|
| Secondary | Patient Global Assessment (PGA) of Pain Control | An assessment of the patient's pain, made by the patient themselves, made at 30 minute intervals up to 120 min after the intervention, or until discharge, or administration of rescue medication | Patient Global Assessment of Pain Control at 30 min | Posted | Count of Participants | Participants | every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) |
|
|
|
|
| Secondary | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | time-weighted Summed Pain Intensity Difference (SPID) is a statistical measure that calculates the cumulative pain reduction over a period of time by summing up the differences between baseline pain and current pain at various time points. The range for the SPID is 0-100 per time point, A score of 0 indicates no pain, a score of 100 indicating the worst pain intensity difference. Some patients did not participate in the SPID due to discharge or requiring rescue narcotic administration. | Posted | Mean | Standard Deviation | units on a scale | every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) |
|
|
|
|
| Secondary | Number of Participants Who Needed Rescue Narcotic Doses | Count of patients requiring additional pain medication after recieving the intervention (sufentanil) or the standard care control. | Posted | Count of Participants | Participants | at 30 minutes following administration and during ED stay (up to 120 minutes) |
|
|
|
|
| Secondary | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | The Six Item Screener (SIS) is a simple assessment of cognitive impairment. It asks 6 questions, 3 based on recall and 3 based on orientation, each question is worth 1 point. The score can range between 0 and 6 correct answers. Higher numbers of correct answers indicated better outcomes (less cognitive impairment). Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. | Posted | Count of Participants | Participants | at 30 minutes following administration |
|
|
|
|
| Secondary | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Acceptability of pain treatment to health care providers based on a subjective assessment of the patients facial expressions, behavior, physical presentation and reported pain level. Nurses caring for the participant following treatment with the study drug were asked to characterize their patients pain relief as Poor, Fair, Good or Excellent. | Posted | Count of Participants | Participants | at 30 minutes following administration |
|
|
|
|
| Secondary | Number of Participants With Hypoxia Needing Supplemental Oxygen | The number of patients with an SpO2 less than 90 percent receiving supplemental oxygen | Posted | Count of Participants | Participants | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
|
|
|
|
| Secondary | Number of Participants With Hypotension | systolic blood pressure less than 90mmHg | Posted | Count of Participants | Participants | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
|
|
|
|
| Secondary | Number of Participants With Nausea | Posted | Count of Participants | Participants | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
|
|
|
|
| Secondary | Number of Participants With Vomiting | Posted | Count of Participants | Participants | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
|
|
|
| Secondary | Number of Participants With Headache | Posted | Count of Participants | Participants | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
|
|
|
|
| Secondary | Number of Participants With Dizziness Requiring Treatment | Dizziness requiring treatment | Posted | Count of Participants | Participants | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
|
|
|
|
| Secondary | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | The Number of participants that had a 10 point reduction in their VNRS @ 30min intervals to 120min | Posted | Count of Participants | Participants | Time to a 10 point reduction in VNRS following administration of study drug. Participants were followed to 120 min or discharge in 30 min intervals |
|
|
|
|
| Secondary | Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management | Need for advanced airway or bag valve mask ventilation | Posted | Count of Participants | Participants | From drug administration up to 120 min following administration |
|
|
|
| Secondary | Richmond Agitation-Sedation Scale (RASS) | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. | RASS @ 30 min | Posted | Count of Participants | Participants | Assessed at 30 minutes after administration |
|
|
|
|
| Secondary | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. | Posted | Count of Participants | Participants | RASS @ 60 min |
|
|
|
|
| Secondary | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. | Posted | Count of Participants | Participants | RASS @ 90 minutes |
|
|
|
|
| Secondary | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. | Posted | Count of Participants | Participants | RASS @ 120 min |
|
|
|
|
| 0 |
| 76 |
| 7 |
| 76 |
| 5 |
| 76 |
| EG001 | Standard Care | Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department | 0 | 74 | 6 | 74 | 4 | 74 |
|
| Hypotension | General disorders | Non-systematic Assessment | Systolic Blood Pressure <90mmHg |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Nausea requiring treatment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Vomiting requiring treatment |
|
| Headache | Nervous system disorders | Non-systematic Assessment | Headache requiring treatment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Dizziness requiring treatment |
|
| Need for an advanced airway | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Need for Bag Valve Mask ventilation or placement of an advanced airway |
|
| Need for Supplemental Oxygen to maintain SpO2 >90% | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
|
| Hypotension | General disorders | Non-systematic Assessment | SBP<90 mmHg |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Nausea requiring treatment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Vomiting requiring treatment |
|
| Headache | Nervous system disorders | Non-systematic Assessment | Requiring Treatment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Requiring treatment |
|
| Need for supplemental oxygen | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Need for Oxygen to maintain SpO2>90% |
|
Not provided
Not provided
| D000284 |
| Administration, Oral |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| 60 minutes |
|
|
| 90 minutes |
|
|
| 120 minutes |
|
|
| Mixed Models Analysis |
Mixed effects ANOVA |
| 0.63 |
| Median Difference (Final Values) |
| 2.92 |
| 2-Sided |
| 95 |
| -9.30 |
| 15.10 |
| Superiority |
| VNRS @ 90 min | Mixed Models Analysis | 0.08 | Unadjusted | Mean Difference (Final Values) | -10.59 | 2-Sided | 95 | -22.39 | 1.21 | Superiority |
| VNRS @90min adjusted | Mixed Models Analysis | Mixed Method ANOVA | 0.28 | Mean Difference (Final Values) | 7.36 | 2-Sided | 95 | -6.13 | 20.80 | Adjusted for ISS | Superiority |
| VNRS @ 120 min | Mixed Models Analysis | 0.18 | Mean Difference (Final Values) | -9.52 | 2-Sided | 95 | -23.60 | 4.56 | Superiority |
| VNRS @ 120min adjusted for sex, HR, RR, and injury type | Mixed Models Analysis | Mixed Method ANOVA | 0.50 | Mean Difference (Final Values) | -5.24 | 2-Sided | 95 | -20.70 | 10.20 | Superiority |
| Fair |
|
| Good |
|
| Excellent |
|
| 60 min |
|
|
| 90 min |
|
|
| 120 min |
|
|
| 90 min |
|
| 120 min |
|
| General Additive Model |
| 0.29 |
| Odds Ratio (OR) |
| 1.72 |
| 2-Sided |
| 95 |
| -1.50 |
| 4.95 |
| Superiority |
| SPID @ 60min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value | Generalized Additive Model | 0.98 | Odds Ratio (OR) | 0.08 | 2-Sided | 95 | -6.63 | 6.47 | Superiority |
| SPID 60 Adjusted Last observed carried forward to address missingness | Generalized Additive Model | 0.85 | Odds Ratio (OR) | 0.61 | 2-Sided | 95 | -5.76 | 6.98 | Superiority |
| SPID @ 90 mn last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value | Generalized Additive Model | 0.8 | Odds Ratio (OR) | -1.26 | 2-Sided | 95 | -8.75 | 11.28 | Superiority |
| SPID 90 min Adjusted last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value | Generalized Additive Model | 0.92 | Odds Ratio (OR) | -0.44 | 2-Sided | 95 | -10.2 | 9.92 | Superiority |
| SPID @ 120 min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value | Generalized Additive Model | 0.64 | Odds Ratio (OR) | -3.18 | 2-Sided | 95 | -10.45 | 16.90 | Superiority |
| SPID 120 Adjusted last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value | Generalized Additive Model | 0.75 | Odds Ratio (OR) | -2.15 | 2-Sided | 95 | -15.60 | 11.30 | Superiority |
| 4 Correct |
|
| 3 Correct |
|
| 2 Correct |
|
| 1 Correct |
|
| 0 Correct |
|
| 0.54 |
| Odds Ratio (OR) |
| -0.28 |
| 2-Sided |
| 95 |
| -1.23 |
| 0.65 |
| Superiority |
| Good |
|
| Excellent |
|
| Ordinal polytomous logistic regression |
| 0.01 |
| Odds Ratio (OR) |
| 2.24 |
| 2-Sided |
| 95 |
| 1.18 |
| 4.29 |
| Superiority |
| Odds Ratio (OR) |
| 0.94 |
| 2-Sided |
| 95 |
| 0.17 |
| 5.04 |
Adjusted for age, sex and SpO2 |
| Superiority |
| Odds Ratio (OR) |
| 0.2 |
| 2-Sided |
| 95 |
| 0 |
| 14.28 |
Adjusted for Heart Rate and Injury Severity Score |
| Superiority |
| Odds Ratio (OR) |
| 1.68 |
| 2-Sided |
| 95 |
| 0.39 |
| 8.60 |
Adjusted for SpO2 |
| Superiority |
| Odds Ratio (OR) |
| 0.41 |
| 2-Sided |
| 95 |
| 0.02 |
| 4.56 |
Adjusted for heart rate |
| Superiority |
| Participants with a 10 point reduction @ 90 min |
|
| Participants with a 10 point reduction @ 120 min |
|
| 0.48 |
| Hazard Ratio (HR) |
| 1.16 |
| 2-Sided |
| 95 |
| 0.75 |
| 1.81 |
| Superiority |
| RASS 2 @ 30 min |
|
| RASS 1 @ 30 min |
|
| RASS 0 @ 30 min |
|
| RASS -1 @ 30 min |
|
| RASS -2 @ 30 min |
|
| RASS -3 @ 30 min |
|
| RASS -4 @ 30 min |
|
| RASS -5 @ 30 min |
|
| 0.96 |
| Odds Ratio (OR) |
| 0.01 |
| 2-Sided |
| 95 |
| -0.16 |
| 0.15 |
| Superiority |
| RASS 2 |
|
| RASS 1 |
|
| RASS 0 |
|
| RASS -1 |
|
| RASS -2 |
|
| RASS -3 |
|
| RASS -4 |
|
| RASS -5 |
|
| 0.84 |
| Odds Ratio (OR) |
| 0.02 |
| 2-Sided |
| 95 |
| -0.19 |
| 0.16 |
| Superiority |
| RASS 2 |
|
| RASS 1 |
|
| RASS 0 |
|
| RASS -1 |
|
| RASS -2 |
|
| RASS -3 |
|
| RASS -4 |
|
| RASS -5 |
|
| 0.91 |
| Odds Ratio (OR) |
| 0.01 |
| 2-Sided |
| 95 |
| -0.20 |
| 0.22 |
| Superiority |
| RASS 2 |
|
| RASS 1 |
|
| RASS 0 |
|
| RASS -1 |
|
| RASS -2 |
|
| RASS -3 |
|
| RASS -4 |
|
| RASS -5 |
|
| 0.63 |
| Odds Ratio (OR) |
| 0.05 |
| 2-Sided |
| 95 |
| -0.30 |
| 0.18 |
| Superiority |