- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413575
Evaluation of the Effects of Intraoperative Ventilation Modes on Perioperative Atelectasis
Evaluation of the Effects of Intraoperative Ventilation Modes on Perioperative Atelectasis in Patients Undergoing Hysterectomy by Lung Ultrasonography
In hysterectomy surgeries, due to factors such as the abdominal nature of the procedure, prolonged operative duration, and the use of the head-down (Trendelenburg) position during surgery, a lobe or a specific region of the lungs may collapse and fail to fill with air in the postoperative period. This condition is referred to as atelectasis.
In this study, the investigators aimed to evaluate the effects of ventilation modes used in the operating room on the development of postoperative atelectasis using lung ultrasonography.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul
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Sancaktepe, Istanbul, Turkey (Türkiye), 34785
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
Patients aged 45 years and older scheduled for hysterectomy surgery with an expected operative duration of more than 2 hours
Patients classified as American Society of Anesthesiologists (ASA) Physical Status Class I, II, or III
Patients for whom planned total intravenous anesthesia was preferred
Exclusion Criteria
Patients younger than 45 years
Patients planned for postoperative intensive care unit monitoring
Patients unable to provide written informed consent
Patients classified as American Society of Anesthesiologists Physical Status Class IV or higher
Patients with a body mass index (BMI) greater than 35
Patients who did not consent to participate in the study
Patients with neuromuscular diseases
Patients with uncontrolled asthma
Patients with chronic obstructive pulmonary disease (COPD), Global Initiative for Chronic Obstructive Lung Disease (GOLD) Class IV
Patients with scoliosis
Patients with a history of pulmonary resection
Patients with chest wall deformities
Patients with a history of spontaneous pneumothorax
Patients for whom inhalational anesthesia was preferred
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Flow-Controlled Ventilation (FCV)
Patients were divided into three groups according to the type of ventilation used.
The group that received flow-controlled ventilation was designated as the FCV group.
In the FCV group, a constant flow is applied during both inspiration and expiration.
In all three groups, lung ultrasonographic evaluation was performed preoperatively and up to 24 hours postoperatively, and the lung ultrasound scores were determined.
Vital signs, ventilation parameters, blood gas analysis, and pain scores were also recorded at specific time intervals.
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Pressure-Controlled Ventilation (PCV)
Patients were divided into three groups according to the type of ventilation used.
The group that received pressure-controlled ventilation was designated as the PCV group.
In the PCV group, the peak airway pressure is controlled.
The mandatory respiratory rate and inspiratory time are also adjusted.
In all three groups, lung ultrasonographic evaluation was performed preoperatively and up to 24 hours postoperatively, and the lung ultrasound scores were determined.
Vital signs, ventilation parameters, blood gas analysis, and pain scores were also recorded at specific time intervals.
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Volume-Controlled Ventilation (VCV)
Patients were divided into three groups according to the ventilation mode used.
The group receiving volume-controlled ventilation (VCV) was designated as the VCV group.
In the VCV group, a specific tidal volume (Vt) was achieved by maintaining a constant flow rate and inspiratory time set on the ventilator, while airway pressure was allowed to vary.
In all three groups, lung ultrasonographic evaluation was performed preoperatively and up to 24 hours postoperatively, and lung ultrasound scores were determined.
Vital signs, ventilation parameters, blood gas analysis results, and pain scores were recorded at predefined time intervals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Lung Ultrasound Score (ΔLUS) From Preoperative Baseline to 24 Hours Postoperatively
Time Frame: Preoperative baseline and 24 hours postoperatively
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Perioperative atelectasis was assessed as the change in Lung Ultrasound Score (ΔLUS) from preoperative baseline to 24 hours postoperatively.
Lung aeration was evaluated using a standardized 12-region scoring system (0-36 scores on a scale).
ΔLUS was calculated as postoperative LUS at 24 hours minus preoperative baseline LUS.
Higher values indicate greater loss of aeration.
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Preoperative baseline and 24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mechanical Power During Intraoperative Ventilation
Time Frame: Intraoperative period
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Mechanical power calculated from ventilator parameters at predefined intraoperative time points.
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Intraoperative period
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Arterial Oxygen Partial Pressure (PaO₂)
Time Frame: Preoperative and at the time of transfer from the Post-Anesthesia Care Unit (PACU) to the ward (PACU discharge).
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PaO₂ measured by arterial blood gas analysis at preoperative baseline and at the time of discharge from the Post-Anesthesia Care Unit (PACU).
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Preoperative and at the time of transfer from the Post-Anesthesia Care Unit (PACU) to the ward (PACU discharge).
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PaO₂/FiO₂ Ratio
Time Frame: Preoperative and at the time of transfer from the Post-Anesthesia Care Unit (PACU) to the ward (PACU discharge).
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PaO₂/FiO₂ ratio was calculated from arterial blood gas analysis using PaO₂ and the fraction of inspired oxygen (FiO₂) at preoperative baseline and at the time of discharge from the Post-Anesthesia Care Unit (PACU).
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Preoperative and at the time of transfer from the Post-Anesthesia Care Unit (PACU) to the ward (PACU discharge).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Lung Ultrasound Score (ΔLUS) During Early Postoperative Period
Time Frame: Preoperative baseline, at discharge from the Post-Anesthesia Care Unit (PACU), and at 2 hours postoperatively
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Change in Lung Ultrasound Score (ΔLUS) calculated as postoperative LUS minus preoperative baseline LUS.
Lung aeration was assessed using a standardized 12-region scoring system (0-36 points).
Positive values indicate increased loss of aeration.
Measurements were obtained at PACU discharge and at postoperative 2 hours.
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Preoperative baseline, at discharge from the Post-Anesthesia Care Unit (PACU), and at 2 hours postoperatively
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Collaborators and Investigators
Publications and helpful links
General Publications
- Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.
- Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
- O'Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030.
- Barnes T, van Asseldonk D, Enk D. Minimisation of dissipated energy in the airways during mechanical ventilation by using constant inspiratory and expiratory flows - Flow-controlled ventilation (FCV). Med Hypotheses. 2018 Dec;121:167-176. doi: 10.1016/j.mehy.2018.09.038. Epub 2018 Sep 24.
- Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14.
- Gertler R. Respiratory Mechanics. Anesthesiol Clin. 2021 Sep;39(3):415-440. doi: 10.1016/j.anclin.2021.04.003.
- Gattinoni L, Pelosi P, Crotti S, Valenza F. Effects of positive end-expiratory pressure on regional distribution of tidal volume and recruitment in adult respiratory distress syndrome. Am J Respir Crit Care Med. 1995 Jun;151(6):1807-14. doi: 10.1164/ajrccm.151.6.7767524.
- Protti A, Maraffi T, Milesi M, Votta E, Santini A, Pugni P, Andreis DT, Nicosia F, Zannin E, Gatti S, Vaira V, Ferrero S, Gattinoni L. Role of Strain Rate in the Pathogenesis of Ventilator-Induced Lung Edema. Crit Care Med. 2016 Sep;44(9):e838-45. doi: 10.1097/CCM.0000000000001718.
- Ball L, Hemmes SNT, Serpa Neto A, Bluth T, Canet J, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Schultz MJ, Pelosi P; LAS VEGAS investigators; PROVE Network; Clinical Trial Network of the European Society of Anaesthesiology. Intraoperative ventilation settings and their associations with postoperative pulmonary complications in obese patients. Br J Anaesth. 2018 Oct;121(4):899-908. doi: 10.1016/j.bja.2018.04.021. Epub 2018 Jun 2.
- Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
- Hedenstierna G, Edmark L. Mechanisms of atelectasis in the perioperative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):157-69. doi: 10.1016/j.bpa.2009.12.002.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ivstrh 2024/241
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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