Trial Outcomes & Findings for A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques (NCT NCT00954733)

Results Overview

Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

1 hour

Results posted on

2014-07-24

Participant Flow

Subjects were approached in the pre operative area sequentially.

Participant milestones

Participant milestones
Measure	All Participants All participants undergoing surgery
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All participants undergoing surgery
Overall Study blood gas machine did not work	1

Baseline Characteristics

A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=40 Participants All participants in the study
Region of Enrollment United States	40 participants n=99 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	42 years n=99 Participants
Sex: Female, Male Female	40 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 hour

Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2

Outcome measures

Outcome measures
Measure	All Participants n=39 Participants All participants undergoing surgery
TcCo2 vs PACo2 Difference	3.2 mmHG Standard Deviation 2.6

Adverse Events

All Participants

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

Gildaasio De Oliveira, M.D.

Northwestern University

Phone: 312-472-3573

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place