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| Name | Class |
|---|---|
| Revolutionary Medical Devices, Inc. | UNKNOWN |
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Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy.
The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.
Colonoscopy has become an essential part of the patient management, especially in the field of colorectal cancer prevention. About 15 million colonoscopies were done in the United States in 2012. Data from United States and European countries suggest that the majority of investigations are performed with the aid of sedation. Since sedation can cause significant respiratory depression, resulting in hypoxia, especially in obese and elder populations who are more likely to undergo colonoscopy, usually oxygen is provided to patients via a nasal cannula to minimize the risk of hypoxia.
Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy.
The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen via nasal cannula (Standard of Care) | Active Comparator | The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. |
|
| Oxygen via SuperNO2VA nasal mask | Experimental | The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen via nasal cannula | Device | Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Intervention | The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management. | Usually 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Receiving Interventions for Airway Management | Number of subjects receiving interventions for airway management including chin up and/or jaw thrust, oral and/or nasal airway insertion, mask ventilation, intubation with endotracheal tube (ETT) or laryngeal mask airway (LMA) insertion | Duration of colonoscopy procedure (usually 30 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koffi M Kla, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31313720 | Derived | Bai Y, Xu Z, Chandrashekar M, St Jacques PJ, Liang Y, Jiang Y, Kla K. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019 Sep;36(9):633-640. doi: 10.1097/EJA.0000000000001052. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxygen Via Nasal Cannula (Standard of Care) | The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center. |
| FG001 | Oxygen Via SuperNO2VA Nasal Mask | The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxygen Via Nasal Cannula (Standard of Care) | The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center. |
| 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 | Time to First Intervention | The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management. | Posted | Mean | Standard Deviation | minutes | Usually 5 minutes |
|
From the beginning of the study until discharge from the Post Anesthesia Recovery Room (Usually 2 hours)
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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 | Oxygen Via Nasal Cannula (Standard of Care) | The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Koffi Kla, MD | Vanderbilt University Medical Center | 615-343-9419 | koffi.m.kla@vumc.org |
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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 | Jun 26, 2017 | Jan 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Oxygen via SuperNO2VA nasal mask | Device | The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. |
|
| Duration of Intervention | Duration of intervention | Duration of colonoscopy procedure (usually 30 minutes) |
| Oxygen Saturation Reading- Median | Oxygen saturation reading- Median | Duration of colonoscopy procedure (usually 30 minutes) |
| Oxygen Saturation- Lowest Reading | Oxygen saturation- Lowest reading | Duration of colonoscopy procedure (usually 30 minutes) |
| Number of Participants With Oxygen Saturation- Reading Below 90% | Number of participants with oxygen saturation- reading below 90% | Duration of colonoscopy procedure (usually 30 minutes) |
| Tidal Volume (VT) | Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation. | Duration of colonoscopy procedure (usually 30 minutes) |
| Respiratory Rate (RR) | Respiratory Rate (RR) | Duration of colonoscopy procedure (usually 30 minutes) |
| Minute Ventilation (MV) | Minute ventilation (MV) | Duration of colonoscopy procedure (usually 30 minutes) |
| Withdrawal by Subject |
|
| Screen fail |
|
| Physician Decision |
|
| BG001 | Oxygen Via SuperNO2VA Nasal Mask | The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
|
|
| Secondary | Number of Subjects Receiving Interventions for Airway Management | Number of subjects receiving interventions for airway management including chin up and/or jaw thrust, oral and/or nasal airway insertion, mask ventilation, intubation with endotracheal tube (ETT) or laryngeal mask airway (LMA) insertion | Posted | Count of Participants | Participants | Duration of colonoscopy procedure (usually 30 minutes) |
|
|
|
| Secondary | Duration of Intervention | Duration of intervention | Posted | Mean | Standard Deviation | minutes | Duration of colonoscopy procedure (usually 30 minutes) |
|
|
|
| Secondary | Oxygen Saturation Reading- Median | Oxygen saturation reading- Median | Posted | Median | Inter-Quartile Range | percentage of oxygen saturation | Duration of colonoscopy procedure (usually 30 minutes) |
|
|
|
| Secondary | Oxygen Saturation- Lowest Reading | Oxygen saturation- Lowest reading | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Duration of colonoscopy procedure (usually 30 minutes) |
|
|
|
| Secondary | Number of Participants With Oxygen Saturation- Reading Below 90% | Number of participants with oxygen saturation- reading below 90% | Posted | Count of Participants | Participants | Duration of colonoscopy procedure (usually 30 minutes) |
|
|
|
| Secondary | Tidal Volume (VT) | Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation. | Posted | Mean | Standard Deviation | milliliters | Duration of colonoscopy procedure (usually 30 minutes) |
|
|
|
| Secondary | Respiratory Rate (RR) | Respiratory Rate (RR) | Posted | Mean | Standard Deviation | respiration per minute | Duration of colonoscopy procedure (usually 30 minutes) |
|
|
|
| Secondary | Minute Ventilation (MV) | Minute ventilation (MV) | Posted | Mean | Standard Deviation | Liters per minute | Duration of colonoscopy procedure (usually 30 minutes) |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Oxygen Via SuperNO2VA Nasal Mask | The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. | 0 | 70 | 0 | 70 | 0 | 70 |
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| 4 minutes after induction |
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| 6 minutes after induction |
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| 5 minutes before end of procedure |
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| end of procedure |
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| 4 minutes after induction |
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| 6 minutes after induction |
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| 5 minutes before end of procedure |
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| end of procedure |
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| 4 minutes after induction |
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| 6 minutes after induction |
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| 5 minutes before end of procedure |
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| end of procedure |
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| 4 minutes after induction |
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| 6 minutes after induction |
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| 5 minutes before end of procedure |
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| end of procedure |
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| 4 minutes after induction |
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| 6 minutes after induction |
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| 5 minutes before end of procedure |
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| end of procedure |
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