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Trial record 9 of 667 for:    CARBON DIOXIDE AND arterial

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

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ClinicalTrials.gov Identifier: NCT00954733
Recruitment Status : Completed
First Posted : August 7, 2009
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Surgery
Hypoventilation
Intervention Other: Arterial blood draw
Enrollment 40
Recruitment Details Subjects were approached in the pre operative area sequentially.
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description All participants undergoing surgery
Period Title: Overall Study
Started 40
Completed 39
Not Completed 1
Reason Not Completed
blood gas machine did not work             1
Arm/Group Title All Participants
Hide Arm/Group Description All participants in the study
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
42 possible participants between 18-65 years of age were approached to participate in the study . 40 gave written informed consent.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
42
(27 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
40
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title TcCo2 vs PACo2 Difference
Hide Description Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants undergoing surgery
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: mmHG
3.2  (2.6)
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description All participants undergoing surgery
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants
Affected / at Risk (%)
Total   0/40 (0.00%) 
We only included healthy, female subjects without significant co-morbidities which limit our ability to generalize our findings to elderly and sicker patients who bay benefit the most from this monitoring.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gildaasio De Oliveira, M.D.
Organization: Northwestern University
Phone: 312-472-3573
EMail: gjr@northwestern.edu
Layout table for additonal information
Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT00954733     History of Changes
Other Study ID Numbers: STU00004382
First Submitted: August 5, 2009
First Posted: August 7, 2009
Results First Submitted: June 25, 2014
Results First Posted: July 24, 2014
Last Update Posted: July 24, 2014