Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds.
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds. In addition, secondary measures will include evaluation of mechanism and degree of respiratory depression associated with hypoxia and hypoventilation by characterizing changes in minute ventilation, tidal volume, and respiratory rate as well as the rate and degree of airway obstruction. The investigators hypothesize that the addition of nasal continuous positive airway pressure in the intervention arm will lead to decreased obstruction as positive pressure will stent open the obstructed airway. Depth of anesthesia will be monitored by Bispectral Index and investigators hypothesize that the degree of hypoventilation, obstruction, and will be significantly lower in the intervention arm compared to the control arm. Further, the depth of anesthesia will be independent of total propofol dose received. While the primary outcome in this study is hypoxia, investigators also seek to marry end tidal carbon dioxide with minute ventilation and transcutaneous carbon dioxide measurement to better understand the total effects of sedation on respiration. Thus the study will also serve to evaluate which mode(s) of respiratory monitoring might be the best possible intervention to enhance safety during procedural sedation in the future. Further, investigators suspect that the amplitude of end tidal carbon dioxide will not predict the degree of respiratory depression seen with other monitors. In addition, investigators will measure serum short chain fatty acid concentrations as a predictor and possible mechanism for differences in individual variability in anesthesia induced respiratory depression.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Nasal Mask | Experimental | Nasal anesthesia mask with positive pressure |
|
| Control: Nasal cannula | Active Comparator | Nasal Cannula with standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Mask | Device | Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event | Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds. | Approximately 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring | Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg). | Approximately 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Short Chain Fatty Acid Concentration | Measure baseline short chain fatty acids in subjects undergoing procedural sedation for endoscopy and correlate the concentration with the degree of respiratory depression by respiratory volume monitoring and transcutaneous carbon dioxide. | Approximately 1 hour |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laeben Lester, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients were recruited in the Endoscopy suite at Johns Hopkins Hospital.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: Nasal Mask | Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve |
| FG001 | Control: Nasal Cannula | Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Nasal Mask | Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve |
| BG001 | Control: Nasal Cannula |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event | Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds. | Posted | Count of Participants | Participants | Approximately 1 hour |
|
Discharge from endoscopy unit, up to 1 week.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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 | Intervention: Nasal Mask | Nasal anesthesia mask with positive pressure Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laeben Lester | The Johns Hopkins University | 410-955-7519 | llester4@jhmi.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 | Nov 16, 2017 | Oct 22, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2017 | Jul 15, 2020 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control: Nasal Cannula | Device | Nasal cannula as per usual care |
|
|
| Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring |
Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation. |
| Approximately 1 hour |
| Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation | Correlate respiratory volume monitoring transcutaneous carbon dioxide measurement with number of airway maneuvers to identify mechanism of hypoventilation as predominately obstructive or due to respiratory rate or tidal volume. | Approximately 1 hour |
| Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy | Depth of anesthesia by processed electroencephalogram (EEG) bispectral analysis, which is a standard monitor of anesthetic depth using a calibrated dimensionless index that ranges from 0 to 100, with lower numbers corresponding to a deeper anesthetic state. | Approximately 1 hour |
| Hypoxia Duration | The total time in seconds of oxygen saturation below 90 percent will be recorded | Approximately 1 hour |
| Total Number of Hypoxic Events in Subjects That Experienced Hypoxia | In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded. | Approximately 1 hour |
Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring | Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg). | 11 participants from intervention group and 9 participants from control group were not assessed for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Approximately 1 hour |
|
|
|
| Secondary | Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring | Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation. | Only 43 in the intervention group and 40 in the control group had sufficient data to be analyzed. | Posted | Mean | Standard Deviation | percentage of decrease | Approximately 1 hour |
|
|
|
| Secondary | Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation | Correlate respiratory volume monitoring transcutaneous carbon dioxide measurement with number of airway maneuvers to identify mechanism of hypoventilation as predominately obstructive or due to respiratory rate or tidal volume. | This data was not collected. | Posted | Approximately 1 hour |
|
|
| Secondary | Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy | Depth of anesthesia by processed electroencephalogram (EEG) bispectral analysis, which is a standard monitor of anesthetic depth using a calibrated dimensionless index that ranges from 0 to 100, with lower numbers corresponding to a deeper anesthetic state. | 5 participants from intervention group and 7 participants from control group were not assessed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Approximately 1 hour |
|
|
|
| Secondary | Hypoxia Duration | The total time in seconds of oxygen saturation below 90 percent will be recorded | This data was not collected. | Posted | Approximately 1 hour |
|
|
| Secondary | Total Number of Hypoxic Events in Subjects That Experienced Hypoxia | In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded. | The 3 patients in nasal mask arm and 16 in nasal cannula arm experienced hypoxia. | Posted | Number | hypoxic events | Approximately 1 hour |
|
|
|
| Other Pre-specified | Short Chain Fatty Acid Concentration | Measure baseline short chain fatty acids in subjects undergoing procedural sedation for endoscopy and correlate the concentration with the degree of respiratory depression by respiratory volume monitoring and transcutaneous carbon dioxide. | Not Posted | Approximately 1 hour | Participants |
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Control: Nasal Cannula | Nasal Cannula with standard care Control: Nasal Cannula: Nasal cannula as per usual care | 0 | 57 | 0 | 57 | 0 | 57 |
Not provided
Not provided