- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07305129
PCV vs VCV in Low-Flow Anesthesia
Pressure-Controlled Versus Volume-Controlled Ventilation in Low-Flow Anesthesia: A Randomized Controlled Trial on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Function
The aim of this observational study is to investigate the effects of ventilation modes on intraoperative and postoperative lung functions in patients under general anesthesia.
This study aimed to compare the effects of low-flow anesthesia on intraoperative respiratory mechanics and early postoperative pulmonary function between PCV and VCV in ASA I-II adult patients.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Çorum
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Çorum, Çorum, Turkey (Türkiye), 19030
- Hitit University Erol Olcok Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 18-65 years and American Society of Anesthesiologists (ASA) physical status I-II.
Exclusion Criteria:
- morbid obesity (BMI > 35 kg/m²),
- scoliosis or thoracic deformity,
- restrictive or obstructive lung disease,
- prior thoracic or upper abdominal surgery,
- history of major thoracic trauma or congenital chest wall anomaly,
- active smoking or chronic use of corticosteroids,
- β-agonists, bronchodilators, or antihistamines,
- anticipated difficult airway
- severe hypoxemia (SpO₂ < 90%) during induction.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Ppeak (cmH₂O) at each time point; between-group difference.
Time Frame: From post-intubation baseline until 30 minutes after initiation of low-flow anesthesia (approximately 45 minutes total).
|
Peak inspiratory pressure will be measured using the anesthesia workstation's built-in pressure monitoring system.
Ppeak (cmH₂O) values will be automatically recorded at predefined time points: baseline after intubation, before low-flow transition, and 5, 10, 15, and 30 minutes after transition to low-flow anesthesia.
Group comparisons will be reported as mean ± SD and analyzed for intergroup differences.
|
From post-intubation baseline until 30 minutes after initiation of low-flow anesthesia (approximately 45 minutes total).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in inspiratory score (number of balls raised).
Time Frame: Baseline to 30 minutes after initiation of low-flow anesthesia and Preoperative baseline and postoperative 1 hour
|
Mean airway pressure will be measured continuously by the anesthesia machine.
Values will be recorded at the same predefined time points as Ppeak.
Data will be reported as mean ± SD.
Dynamic compliance (mL/cmH₂O) will be calculated using the ventilator's automated measurement system (tidal volume / (Ppeak - PEEP)).
Values will be recorded at identical intraoperative time points.
Data will be reported as mean ± SD.
Inspiratory effort will be assessed using the Triflo incentive spirometer by recording the number of balls elevated on a single maximal inspiratory attempt (range: 0-3).
Measurements will be taken preoperatively and 1 hour postoperatively in the recovery unit.
|
Baseline to 30 minutes after initiation of low-flow anesthesia and Preoperative baseline and postoperative 1 hour
|
Collaborators and Investigators
Sponsor
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
Keywords
Other Study ID Numbers
- 2023-64
- hulya topcu (Other Identifier: Erol Olcok Corum Training and Research Hospital)
- serhat ozciftci (Other Identifier: Erol Olcok Corum Training and Research Hospital)
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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