Trial Outcomes & Findings for Comparison of Oxygenation Between Nasal PAP vs Nasal During Propofol-based Sedation for EUS (NCT NCT04306211)

NCT ID: NCT04306211

Last Updated: 2022-11-03

Results Overview

Compare the incidence, duration, and severity of oxygen desaturation

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

60 minutes.

Results posted on

2022-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Facial Mask facial mask for oxygen delivery SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery	SuperNO2VA SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Oxygenation Between Nasal PAP vs Nasal During Propofol-based Sedation for EUS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Facial Mask n=6 Participants facial mask for oxygen delivery SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery	SuperNO2VA n=5 Participants SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask SuperNO2VA: SUPERNO2VA is nasal PAP device for oxygen delivery	Total n=11 Participants Total of all reporting groups
Age, Continuous	52.6 years n=5 Participants	56.17 years n=7 Participants	54.55 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes.

Population: Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll.

Compare the incidence, duration, and severity of oxygen desaturation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 minutes.

Population: Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll.

Compares amounts of Propofol for induction and entire procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 120 minutes

Population: Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll.

Compare MOAAS immediately prior to intubation and during procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 minutes

Population: Data cannot be analyzed due to unreliability. There was inadequate staff training to work the device and insufficient patients to enroll.

Compare incidence, duration and reason for procedural interruptions

Outcome measures

Outcome data not reported

Adverse Events

Facial Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SuperNO2VA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John M. DeWitt, MD

Indiana University

Phone: 317-944-0980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place