Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction

Study Overview
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Brief Summary
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The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).

Official Title
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Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction: a Prospective Randomized Controlled Trial.

Conditions
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Obstructive Sleep Apnea, Obesity

Intervention / Treatment
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* Device: Standard care with a facemask.
* Device: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing colonoscopy American Society of Anesthesiology (ASA) Physical Status I-III BMI ≥35 kg/m2 and/or documented or suspected Obstructive Sleep Apnea Exclusion Criteria: Inpatient status Active Congestive Heart Failure Exacerbation Untreated ischemic heart disease Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma Emergent procedures Pregnancy Previous enrollment in this study Inability to provide informed consent Additional medical testing planned for the same day History of allergic reaction to Propofol Tracheostomy Supra-glottic or sub-glottic tumor Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon). Prisoners Unable to fit SuperNoVa

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: Standard care with a facemask.<br> | Device: Standard care with a facemask.<br>* The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)<br>|
| Experimental: Group B: SuperNO2VA™EtCO2<br> | Device: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)<br>* The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken from initiation of induction to the first airway intervention |  | end of endoscopy procedure( about 45 minutes form start of procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of propofol administered during induction |  | Within 5 minutes of the start of anesthesia | 
| Total amount of propofol administered during the procedure |  | end of procedure (about 45 minutes after start) | 
| Change in alertness of subject as assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS) | This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness | prior to endoscopic intubation,during the procedure | 
| Time taken from induction to endoscopic insertion |  | within 5 minutes of start of sedation | 
| Incidence of procedural interruptions as assessed by the number of times the endoscope is removed from the patient |  | end of procedure (about 45 minutes form start) | 
| Duration of procedural interruptions as assessed by the length of time the endoscope is removed from the patient |  | end of procedure (about 45 minutes form start) | 
| Number of participants who received airway maneuvers |  | end of procedure (about 45 minutes form start) | 
| Time taken for airway maneuvers |  | end of procedure (about 45 minutes form start) | 
| Reason for airway maneuvers |  | end of procedure (about 45 minutes form start) | 
| Time taken for the entire procedure |  | end of procedure (about 45 minutes form start) | 
| Recovery time as assessed by the time when subject was ready for discharge |  | at time of discharge( about one hour form end of procedure) | 
| Recovery time as assessed by the actual time when subject was discharged |  | at time of discharge( about one hour form end of procedure) | 
| Patient satisfaction as assessed by the visual analog scale (VAS) | This will be scored from 0-10, a higher score indicating more satisfaction | at time of discharge(about one hour form end of procedure) | 
| Number of participants that tolerated the SuperNO2VA™EtCO2 |  | from start of procedure to end of procedure (about 45 minutes) | 
| Anesthesiologist satisfaction score as assessed by the visual analog scale (VAS) | This will be scored from 0-10, a higher score indicating more satisfaction | end of procedure | 
| Number of participants that had incidences of cardiac complications |  | from start of procedure to end of procedure (about 45 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, total IV anesthesia, obesity, colonoscopy, Nasal cpap