- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04281589
End-tidal Carbon Dioxide Monitoring in Low Tidal Volume Ventilation (ETCO2)
Does End-Tidal Carbon Dioxide Value Show The Adequacy Of Ventilation In Low Tidal Volume Ventilation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The patients were grouped as follows: Group 1, if the tidal volume is 4 ml/kg; Group 2, if TV=6 ml/kg; Group 3, if TV=8 ml/kg; and Group 4, if TV=10 ml/kg. It was determined how many breaths per minute (minute ventilation) would be given with tidal volume x respiratory rate=6 L. The patients were ventilated with the same ventilation parameters for 30 minutes and then arterial blood gas analysis was performed. Arterial blood gas was collected at t1 for group 1, t2 for group 2, t3 for group 3, and t4 for group 4. The ETCO2 value, Peak pressure (Ppeak), Plateau pressure (Pplato), mean airway pressure (Pmean) values were recorded at the time of arterial blood gas collection. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), peak heart rate (PHR) values were evaluated. The patients with a mean arterial pressure of less than 65 mmHg were excluded from the study. Partial arterial oxygen pressure (PaO2), partial arterial carbon dioxide pressure (PaCO2), oxygen saturation (SO2) values were recorded from the arterial blood gas analysis. P (a-ET) CO2 gradient value was calculated.
The groups were compared, in each patient, under the same conditions, when the different tidal volume was applied, how the ETCO2 monitorization, PaO2 values and hence the P (a-ET) CO2 gradient changed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul, Turkey
-
Istanbul, Istanbul, Turkey, Turkey, 34000
- Döndü Genç Moralar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
American Society of Anesthesiologists (ASA) classification 1, 2 risk group
Head and neck surgery under general anesthesia lasting more than 120 minutes and who progressed normotensive.
Exclusion Criteria:
Cardiac disease
Pulmonary disease
Obese patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1
tidal volüm is 4 ml/kg
|
we will increased fi02
|
EXPERIMENTAL: Group 2
tidal volüm is 6 ml/kg
|
we will increased fi02
|
EXPERIMENTAL: Group 3
tidal volüm is 8 ml/kg
|
we will increased fi02
|
EXPERIMENTAL: Group 4
tidal volüm is 10 ml/kg
|
we will increased fi02
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
P (a-ET) CO2 gradient
Time Frame: 120 minutes
|
The groups were compared, in each patient, under the same conditions, when the different tidal volume was applied, how the ETCO2 monitorization, PaCO2 values and hence the P (a-ET) CO2 gradient changed.
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Partial arterial oxygen pressure (PaO2)
Time Frame: 120 minutes
|
Partial arterial oxygen pressure (PaO2) were recorded from the arterial blood gas analysis
|
120 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- dondum
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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