NCT07680881

Brief Summary

This prospective single-centre observational study compared two intraoperative mechanical ventilation modes, volume-controlled ventilation (VCV) and VCV with AutoFlow/AF, in adults undergoing elective surgery in the prone position. The ventilation mode was selected by the attending anaesthesiologist as part of routine clinical care; the investigators did not assign it. Perioperative atelectasis was assessed using a modified bilateral 12-zone lung ultrasound score obtained before induction of anaesthesia and after extubation, and oxygenation was assessed using the alveolar-arterial oxygen gradient calculated from an intraoperative arterial blood gas sample. The study also examined whether the effect of ventilation mode on atelectasis differed according to obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
Last Updated

July 29, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

June 26, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Lung ultrasoundAtelectasisProne positionMechanical ventilationAlveolar-arterial oxygen gradient

Outcome Measures

Primary Outcomes (1)

  • Postoperative modified lung ultrasound score

    Modified bilateral 12-zone lung ultrasound score assessed after surgery and compared between ventilation modes. Each hemithorax was divided into anterior, lateral and posterior regions, and each region was scored for loss of aeration, with a higher total score indicating greater atelectasis.

    At least 30 minutes after extubation

Secondary Outcomes (2)

  • Alveolar-arterial oxygen gradient

    15 minutes after prone positioning

  • Ventilation-mode by obesity interaction on postoperative lung ultrasound score

    At least 30 minutes after extubation

Study Arms (2)

VCV

Patients managed intraoperatively with volume-controlled ventilation, as chosen by the attending anaesthesiologist.

VCV-AF

Patients managed intraoperatively with Volume-Controlled Ventilation with AutoFlow ventilation, as chosen by the attending anaesthesiologist.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18 to 65 years with American Society of Anesthesiologists physical status I or II and a body mass index below 35 kg/m2, scheduled for elective surgery in the prone position at a single tertiary care hospital. Patients were grouped according to the intraoperative ventilation mode selected by the attending anaesthesiologist (volume-controlled ventilation or volume-controlled ventilation with Autoflow).

You may qualify if:

  • Consented adults aged 18 to 65 years American Society of Anesthesiologists (ASA) physical status I or II Body mass index below 35 kg/m2 Scheduled for elective surgery in the prone position Oriented and cooperative

You may not qualify if:

  • No consent Pre-existing pulmonary disease Any perioperative lung pathology Inability to complete postoperative lung ultrasound assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cemil Tasciogu Research and Training Hospital

Istanbul, Sisli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 26, 2026

First Posted

July 2, 2026

Study Start

March 1, 2024

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

July 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations