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Significant impact of COVID pandemic on ability to conduct study
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At the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (BiPAP; oxygen via face mask) and heated high flow nasal cannula oxygen (HFNC; oxygen via nasal cannula) to see if this method reduces the likelihood of re-intubation.
It is clinically challenging to predict when patients can be successfully removed from mechanical ventilation (MV). Liberating high-risk patients such as the elderly and those with complex, chronic cardiac or pulmonary diseases from MV is particularly challenging.
Evidence from randomized trials and meta-analyses suggests that the type of postextubation supportive care provided, such as oxygen delivery via nose or mouth, may affect the risk of reintubation. However, it is unclear which of many possible postextubation management protocols results in the best patient outcomes, particularly for this subset of high-risk patients.
The purpose of this study is therefore to assess a standardized combined protocol of postextubation oxygen delivery consisting of early, alternating BiPAP with HFNC over 24 hours following extubation. BiPAP and HFNC are both currently provided to patients as standard of care, based on clinician judgement; however, the timing and nature of the methods are variable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: alternating BiPAP and HFNC | Experimental | Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation |
|
| Historical Control: standard of care | No Intervention | A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiPAP | Device | Bilevel Positive Airway Pressure (BiPAP) oxygen administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-intubation Within 72 Hours | The number of patients who require re-intubation | 72 hours following extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Re-intubation Within 1 Week | The number of patients who require re-intubation | 1 week following extubation |
| Length of Stay | Hospital length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kiran Devulapally, MD | OhioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OhioHealth Grant Medical Center | Columbus | Ohio | 43215 | United States |
Two participants in the experimental group withdrew from the study prior to intervention. One participant in the experimental group withdrew consent at time of regained capacity. Because the study was terminated (halted prematurely) no data were collected for the historical control group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Alternating BiPAP and HFNC | Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration |
| FG001 | Historical Control: Standard of Care | A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Because the prospective group was terminated, no data collection for the historical control was collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Alternating BiPAP and HFNC | Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration |
| BG001 | Historical Control: Standard of Care |
| 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 | Re-intubation Within 72 Hours | The number of patients who require re-intubation | Because the study was terminated (halted prematurely), no historical control data were collected | Posted | Number | participants | 72 hours following extubation |
|
Through hospital discharge, and average of 10.9 days.
All patients were assessed for adverse events through hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: Alternating BiPAP and HFNC | Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kiran Devulapally | OhioHealth | 614-566-9143 | kiran.devulapally@ohiohealth.com |
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| 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 | Sep 23, 2020 | Nov 22, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 23, 2020 | Jan 4, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007040 | Hypoventilation |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| HFNC | Device | Heated High Flow Nasal Cannula oxygen administration |
|
| Through hospital discharge, an average of 10.9 ± 1.91 days |
| Ventilator Time | The total duration of time patients spend on a ventilator | Through hospital discharge, an average of 10.9 ± 1.91 days |
| Mortality | The proportion of patients who expire during the hospital stay | Through hospital discharge, an average of 10.9 ± 1.91 days |
| Adverse Event Rate | The proportion of patients experiencing an adverse event | Through 1 week following extubation |
| 30-day Readmission | The proportion of patients who require re-admission within 30 days of discharge | 30 days following discharge |
A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Re-intubation Within 1 Week | The number of patients who require re-intubation | Because the study was terminated (halted prematurely), no historical control data were collected | Posted | Number | participants | 1 week following extubation |
|
|
|
| Secondary | Length of Stay | Hospital length of stay | Because the study was terminated (halted prematurely), no historical control data were collected | Posted | Mean | Standard Deviation | Days | Through hospital discharge, an average of 10.9 ± 1.91 days |
|
|
|
| Secondary | Ventilator Time | The total duration of time patients spend on a ventilator | Because the study was terminated (halted prematurely), no historical control data were collected | Posted | Mean | Standard Deviation | Days | Through hospital discharge, an average of 10.9 ± 1.91 days |
|
|
|
| Secondary | Mortality | The proportion of patients who expire during the hospital stay | Because the study was terminated (halted prematurely), no historical control data were collected | Posted | Count of Participants | Participants | Through hospital discharge, an average of 10.9 ± 1.91 days |
|
|
|
| Secondary | Adverse Event Rate | The proportion of patients experiencing an adverse event | Because the study was terminated (halted prematurely), no historical control data were collected | Posted | Count of Participants | Participants | Through 1 week following extubation |
|
|
|
| Secondary | 30-day Readmission | The proportion of patients who require re-admission within 30 days of discharge | Because the study was terminated (halted prematurely), no historical control data were collected | Posted | Count of Participants | Participants | 30 days following discharge |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Historical Control: Standard of Care | A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |