Micro-stream Capnography in Non-intubated Lean and Obese Patients With and Without Obstructive Sleep Apnea
The Accuracy of End-tidal PCO2 Measurements With Main-stream and Micro-stream Capnography in Non-intubated Lean and Obese Patients With and Without Obstructive Sleep Apnea
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to compare the accuracy of EtPCO2 measurements taken with a nasal cannula using the Microcap (Oridion Capnography Inc., Needham, MA) micro-stream device and the TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). Three groups of non-intubated, spontaneously breathing patients will be included: 1) lean patients without obstructive sleep apnea (OSA); 2) obese patients without OSA; and 3) obese patients diagnosed with OSA. This latter group has a higher prevalence of oral breathing. Additionally, to test the efficacy of oral guides, we propose to compare the accuracy of EtPCO2 measurements from the Microcap with two different nasal cannulas, one with (Smart CapnoLine PlusTM, Oridion Medical, Jerusalem, Israel) and one without (CapnoLineTM H, Oridion Medical) an oral guide to trap gas expired from the mouth. The TG-920 main-stream system requires its purpose-designed YG-122T cannula so that is the only one that will be tested with the Nihon-Kohden product.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 obesity
Started Jun 2006
Typical duration for early_phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 19, 2008
CompletedFirst Posted
Study publicly available on registry
April 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedJuly 20, 2016
July 1, 2016
2.2 years
February 19, 2008
July 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in endtidal PCO2 and PaCO2
In PACU
Study Arms (3)
Lean
ACTIVE COMPARATORLean patients
Obese no OSA
ACTIVE COMPARATORObese patients without osa
Obese osa
ACTIVE COMPARATORObese patients with osa
Interventions
nasal oxygen mask tested to determine accuracy of endtidal CO2 monitoring
CO2 measured via nasal cannula
CO2 measured via nasal cannula
Eligibility Criteria
You may qualify if:
- Normal weight patients (defined as BMI \< 30 kg/m2) without a diagnosis of OSA
- obese patients (BMI \> 35 kg/m2) without a diagnosis of OSA
- obese patients with polysomnography-diagnosed OSA
You may not qualify if:
- Severe pulmonary disease
- Cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Louisville
Louisville, Kentucky, 40202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yusuke Kasuya, MD, PhD
University of Louisville School of Medicine
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2008
First Posted
April 7, 2008
Study Start
June 1, 2006
Primary Completion
August 1, 2008
Study Completion
September 1, 2008
Last Updated
July 20, 2016
Record last verified: 2016-07