NCT07413575

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

November 27, 2025

Results QC Date

March 6, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

Flow-Controlled Ventilation (FCV)Volume-Controlled Ventilation (VCV)Pressure-Controlled Ventilation (PCV)Perioperative atelectasisLung ultrasonographymechanical poweroxygenationlung ultrasound score

Outcome Measures

Primary Outcomes (1)

  • Change in Lung Ultrasound Score (ΔLUS) From Preoperative Baseline to 24 Hours Postoperatively

    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.

    Preoperative baseline and 24 hours postoperatively

Secondary Outcomes (3)

  • Mechanical Power During Intraoperative Ventilation

    Intraoperative period

  • Arterial Oxygen Partial Pressure (PaO₂)

    Preoperative and at the time of transfer from the Post-Anesthesia Care Unit (PACU) to the ward (PACU discharge).

  • PaO₂/FiO₂ Ratio

    Preoperative and at the time of transfer from the Post-Anesthesia Care Unit (PACU) to the ward (PACU discharge).

Other Outcomes (1)

  • Change in Lung Ultrasound Score (ΔLUS) During Early Postoperative Period

    Preoperative baseline, at discharge from the Post-Anesthesia Care Unit (PACU), and at 2 hours postoperatively

Study Arms (3)

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.

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.

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.

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients meet eligibility criteria and will undergone histerectomy surgery from 15/09/2024 to 15/09/2025 in Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Sancaktepe, Istanbul, 34785, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

  • O'Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Limitations and Caveats

The study was conducted at a single center and included only patients undergoing hysterectomy, which may limit generalizability. The observational design and lack of randomization prevent definitive conclusions about causal relationships between ventilation mode and perioperative atelectasis. Advanced hemodynamic and pulmonary monitoring methods were not used, and although computed tomography is the gold standard, lung ultrasonography was used.

Results Point of Contact

Title
Dr. Tuğçe Türkan Tanman
Organization
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital, University of Health Sciences

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

February 17, 2026

Study Start

September 15, 2024

Primary Completion

June 26, 2025

Study Completion

August 5, 2025

Last Updated

May 19, 2026

Results First Posted

May 19, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

We do not plan to share IPD for data security reasons.

Locations