NCT06824506

Brief Summary

Detecting possible atelectasis and other respiratory problems that may develop immediately after extubation via lung ultrasonography can reduce pulmonary complications by performing necessary interventions such as oxygen support, respiratory exercises, mobilization, and non-invasive mechanical ventilation applications at an early stage. In addition, although low-flow anesthesia is frequently used in daily anesthesia practice, publications showing the effects of its use in laparoscopic cholecystectomy operations on pulmonary complications are limited. On this occasion, this study can be presented as a contribution to the literature.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

February 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

February 6, 2025

Last Update Submit

September 23, 2025

Conditions

Keywords

lung ultrasoundlow flow anesthesialaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative atelectasis

    Incidence of postoperative atelectasis determined by lung ultrasonography in patients undergoing laparoscopic cholecystectomy with low-flow anesthesia

    1 hour peroperatively

Secondary Outcomes (1)

  • incidence of other postoperative pulmonary complications

    1 hour peroperatively

Study Arms (1)

Low-Flow Anesthesia Group

As this study is observational in nature, no interventions will be performed by the research team. The study will involve a single group, within which the incidence and prevalence of the outcomes will be assessed.

Other: No-intervention

Interventions

No interventions will be performed by the research team.

Low-Flow Anesthesia Group

Eligibility Criteria

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

All cases that meet the inclusion and exclusion criteria will be included in the study. Patients will be taken to the operating room after being preoperatively evaluated in the observation room. The patient's anesthetic management will be provided by another anesthesiologist who is not participating in the study and is responsible for the patient. Intraoperative data will be obtained from the patient's anesthesia follow-up form and the records of the anesthesia machine. When the patients arrive in the recovery room, postoperative ultrasonographic measurements and other evaluations will be performed and noted. This group will include patients who received general anesthesia using low-flow techniques during the intraoperative period.

You may qualify if:

  • Patients with informed consent
  • Patients scheduled for laparoscopic cholecystectomy
  • Patients with a Body Mass Index between 18-35 kg/m²
  • Patients in the American Society of Anesthesiologist (ASA) 1-2-3 category

You may not qualify if:

  • Patients with emergency surgery planned
  • Patients with ASA 4 and above
  • Patients with lung disease
  • Patients who have undergone thoracic surgery
  • Pregnancy
  • Patients with a preoperative Lung Ultrasound Score of 2 or 3 in any lung region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Ataturk Sanatorium Research and Training Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary AtelectasisCholecystitisGallstones

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesGallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisCholecystolithiasisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mustafa Özgür CIRIK, MD

    Ankara Ataturk Sanatorium Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Necla DERELI, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 13, 2025

Study Start

February 15, 2025

Primary Completion

February 15, 2026

Study Completion

March 1, 2026

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations