N/A
N=139
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
Obstructive Sleep Apnea, Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05524220 ↗Enrolled (actual)
139
Serious AEs
1.4%
Results posted
Mar 2025
Primary outcome: Primary: Time Taken From Initiation of Induction to the First Airway Intervention — 5; 10 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard care with a facemask. (Device); SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Taken From Initiation of Induction to the First Airway Intervention |
5; 10 | — |
| SECONDARY Amount of Propofol Administered During Induction |
70; 75 | — |
| SECONDARY Total Amount of Propofol Administered During the Procedure |
360; 253 | — |
| SECONDARY Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS) |
— | — |
| SECONDARY Time Taken From Induction to Endoscopic Insertion |
2; 3 | — |
| SECONDARY Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient |
0; 0 | — |
| SECONDARY Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient |
— | — |
| SECONDARY Number of Participants Who Received Airway Maneuvers |
16; 29 | — |
| SECONDARY Time Taken for Airway Maneuvers |
172.5; 131 | — |
| SECONDARY Reason for Airway Maneuvers |
2; 9; 12; 10; 2; 9 | — |
| SECONDARY Time Taken for the Entire Procedure |
33; 33.5 | — |
| SECONDARY Recovery Time as Assessed by the Time When Subject Was Ready for Discharge |
48; 46.5 | — |
| SECONDARY Recovery Time as Assessed by the Actual Time When Subject Was Discharged |
81; 77 | — |
| SECONDARY Patient Satisfaction as Assessed by the Visual Analog Scale (VAS) |
10; 10 | — |
| SECONDARY Number of Participants That Tolerated the SuperNO2VA™EtCO2 |
69 | — |
| SECONDARY Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS) |
8.5; 8 | — |
| SECONDARY Number of Participants That Had Incidences of Cardiac Complications |
0; 0 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Patients undergoing colonoscopy
- American Society of Anesthesiology (ASA) Physical Status I-III
- BMI ≥30 kg/m2 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
Data sourced from ClinicalTrials.gov (NCT05524220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.