Trial Outcomes & Findings for 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 (NCT NCT05524220)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

139 participants

Primary outcome timeframe

From Initiation of Induction to the First Airway Intervention (about 16 minutes)

Results posted on

2025-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	Group B: SuperNO2VA™EtCO2 SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): 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)	Group A: Standard Care With a Facemask. Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)
Overall Study STARTED	71	68
Overall Study COMPLETED	71	68
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group B: SuperNO2VA™EtCO2 n=71 Participants SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): 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)	Group A: Standard Care With a Facemask. n=68 Participants Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)	Total n=139 Participants Total of all reporting groups
Age, Continuous	58 years n=71 Participants	54.5 years n=68 Participants	56 years n=139 Participants
Sex: Female, Male Female	46 Participants n=71 Participants	44 Participants n=68 Participants	90 Participants n=139 Participants
Sex: Female, Male Male	25 Participants n=71 Participants	24 Participants n=68 Participants	49 Participants n=139 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	48 Participants n=71 Participants	45 Participants n=68 Participants	93 Participants n=139 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=71 Participants	23 Participants n=68 Participants	46 Participants n=139 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=71 Participants	0 Participants n=68 Participants	0 Participants n=139 Participants
Race/Ethnicity, Customized White	55 Participants n=71 Participants	52 Participants n=68 Participants	107 Participants n=139 Participants
Race/Ethnicity, Customized Black or African-American	15 Participants n=71 Participants	15 Participants n=68 Participants	30 Participants n=139 Participants
Race/Ethnicity, Customized Other	1 Participants n=71 Participants	1 Participants n=68 Participants	2 Participants n=139 Participants
Region of Enrollment United States	71 participants n=71 Participants	68 participants n=68 Participants	139 participants n=139 Participants
American Society of Anesthesiology (ASA) Classification ASA I: A normal healthy patient	0 Participants n=70 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	0 Participants n=68 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	0 Participants n=138 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.
American Society of Anesthesiology (ASA) Classification ASA II: A patient with mild systemic disease	19 Participants n=70 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	21 Participants n=68 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	40 Participants n=138 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.
American Society of Anesthesiology (ASA) Classification ASA III: A patient with severe systemic disease	51 Participants n=70 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	47 Participants n=68 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	98 Participants n=138 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.
American Society of Anesthesiology (ASA) Classification ASA IV: A patient with severe systemic disease that is a constant threat to life	0 Participants n=70 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	0 Participants n=68 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	0 Participants n=138 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.
American Society of Anesthesiology (ASA) Classification ASA V: A moribund patient who is not expected to survive without the operation	0 Participants n=70 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	0 Participants n=68 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	0 Participants n=138 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.
American Society of Anesthesiology (ASA) Classification ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes	0 Participants n=70 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	0 Participants n=68 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.	0 Participants n=138 Participants • Data were not collected from 1 participant in the Group B: SuperNO2VA™EtCO2 arm.
Body Mass Index	36.6 kilograms per square meter n=71 Participants	35.2 kilograms per square meter n=68 Participants	35.9 kilograms per square meter n=139 Participants
Body Mass Index < 30	1 Participants n=71 Participants	2 Participants n=68 Participants	3 Participants n=139 Participants
Body Mass Index 30 ≤ BMI < 40 (obesity)	50 Participants n=71 Participants	49 Participants n=68 Participants	99 Participants n=139 Participants
Body Mass Index ≥ 40 (Class 3 obesity)	20 Participants n=71 Participants	17 Participants n=68 Participants	37 Participants n=139 Participants

PRIMARY outcome

Timeframe: From Initiation of Induction to the First Airway Intervention (about 16 minutes)

Population: 16 participants in the Group B: SuperNO2VA™EtCO2 needed airway intervention. 29 participants in the Group A: Standard care with a facemask needed airway intervention. Only the participants who needed airway intervention were analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Group B: SuperNO2VA™EtCO2 n=16 Participants SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): 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)	Group A: Standard Care With a Facemask. n=29 Participants Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)
Time Taken From Initiation of Induction to the First Airway Intervention	5 minutes Interval 3.0 to 11.0	10 minutes Interval 4.5 to 15.5

SECONDARY outcome

Timeframe: Within 5 minutes of the start of anesthesia

Outcome measures

Outcome measures
Measure	Group B: SuperNO2VA™EtCO2 n=71 Participants SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): 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)	Group A: Standard Care With a Facemask. n=68 Participants Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)
Amount of Propofol Administered During Induction	70 milligrams Interval 50.0 to 100.0	75 milligrams Interval 50.0 to 100.0

SECONDARY outcome

Timeframe: during the procedure (about 45 minutes)

Outcome measures

Outcome measures
Measure	Group B: SuperNO2VA™EtCO2 n=71 Participants SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): 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)	Group A: Standard Care With a Facemask. n=68 Participants Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)
Total Amount of Propofol Administered During the Procedure	360 milligrams Interval 220.0 to 450.0	253 milligrams Interval 200.0 to 455.0

SECONDARY outcome

Timeframe: prior to endoscopic intubation,during the procedure

Population: Data were not collected for this outcome measure because the assessment was not done by the observers. As a result, 0 observers completed the assessment, and therefore, no participants were analyzed in either study arm.

This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 10 minutes of start of sedation