- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02022969
Detection of SpO2-oscillations of Low Ventilated Areas (MAS)
Detection of SpO2-oscillations Caused by Cyclic Recruitment and Derecruitment of Low Ventilated Areas in the Lung (Atelectasis) During Mechanical Ventilation
Study Overview
Status
Conditions
Detailed Description
As stated above cyclical recruitment and derecruitment has been shown a mechanism of VALI. It has further been demonstrated that PaO2-oscillations in the systemic circulation are transmitted to endorgans (i.e. brain, kidney and other peripheral organs). There have no studies quantifying PaO2- or SpO2-oscillations in human subjects. The rationale of this study is to measure non-invasively SpO2-oscillations throughout the respiratory cycle as PaO2 oscillations cannot easily be detected. We will analyse SpO2-oscillations in a cohort of post-operative patients. Atelectasis is a major risk factor for pulmonary complications. As it occurs in up to 90% of surgical patients this phenomenon is highly relevant. Patients with large areas of atelectatic lung tissue are prone to cyclical recruitment and derecruitment and consecutive SpO2-oscillations.
There will be two groups of patients: One with a high risk for atelectasis and one with low risk for atelectasis. The patients are stratified by the type of surgery. Upper abdominal surgery with a duration of more than 2 hours has been shown to be an independent risk factor for atelectasis. Therefore, we chose to assign patients scheduled for abdominal surgery with an anticipated duration of surgery of more than 4 hours for the high-risk group. Patients with neurosurgical procedures with more than 4 hours will be assigned to the low risk group. In each patient the SpO2-oscillations will be measured at three different respiratory rates (RR). The rationale for this is that previous studies showed that cyclical recruitment and derecruitment is dependent on the RR.
Study Type
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- MUW/AKH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Interventional group:
Patients who are at high risk of developing atelectasis at the end of the operation, i.e. having had large abdominal surgery for longer than 4 hours.
Control group:
Patients who are at low risk of developing atelectasis at the end of the operation, i.e. having had neurosurgical treatment without opening the abdomen
Exclusion Criteria:
Interventional + control group:
Age < 18yr, alcohol or drug abuse, pregnancy, participation in another study, skin lesions on the fingers, allergy to patches or other severe allergies, patients who cannot give their consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of SpO2-oscillations caused by cyclic recruitment and derecruitment of atelectasis.
Time Frame: 20 min
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Desaturation of SpO2
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20 min
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAS 1120/2013
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