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Clinical Trials/NCT07753278
NCT07753278Not yet recruitingNot Applicable

Evaluation of the Effects of Fresh Gas Flow Differences on the Lungs Using Ultrasonography in Laparoscopic Cholecystectomy Surgeries

Adiyaman University1 site in 1 country120 target enrollmentStarted: August 15, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Postoperative Lung Ultrasound Score

Study Overview

Brief Summary

This prospective randomized clinical trial aims to evaluate the effects of different fresh gas flow rates on postoperative pulmonary aeration using lung ultrasonography in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomly assigned to receive either low-flow anesthesia (0.5 L/min) or high-flow anesthesia (4 L/min) during maintenance of general anesthesia. The primary objective is to compare postoperative lung ultrasound scores and the incidence of atelectasis between the two groups.

Detailed Description

Pulmonary atelectasis is one of the most common postoperative pulmonary complications following general anesthesia. Fresh gas flow is an important component of inhalational anesthesia and may influence airway humidity, gas exchange, respiratory mechanics, and pulmonary physiology. Although low-flow anesthesia has recognized economic, environmental, and physiological advantages, the effect of different fresh gas flow rates on postoperative lung aeration has not been adequately investigated.

This prospective, randomized, parallel-group clinical trial will be conducted at Adıyaman University Training and Research Hospital. Adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly allocated to either a low-flow group (0.5 L/min) or a high-flow group (4 L/min) after an initial fresh gas flow of 4 L/min for 8 minutes following endotracheal intubation. Standardized anesthesia management will be applied to all participants.

Postoperative lung ultrasonography will be performed 30 minutes after extubation in the post-anesthesia care unit. Lung Ultrasound Score (LUS) and the incidence of postoperative atelectasis will be compared between the study groups. The findings are expected to provide evidence regarding the effects of different fresh gas flow strategies on postoperative pulmonary outcomes and may contribute to optimizing intraoperative anesthesia management.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults aged 18 years or older.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
  • Able and willing to provide written informed consent.

Exclusion Criteria

  • Refusal to participate in the study.
  • History of chronic respiratory disease, including severe asthma, chronic obstructive pulmonary disease (COPD), or bronchiolitis.
  • History of alcohol or substance abuse.
  • Intraoperative airway or respiratory complications during endotracheal intubation or surgery.
  • Life-threatening postoperative complications.
  • Patients with ASA physical status III or higher.

Arms & Interventions

Low Fresh Gas Flow

Active Comparator

Participants will receive general anesthesia with a fresh gas flow rate of 0.5 L/min during the maintenance phase following an initial fresh gas flow of 4 L/min for 8 minutes after endotracheal intubation. Postoperative lung ultrasonography will be performed 30 minutes after extubation.

Intervention: Low Fresh Gas Flow (0.5 L/min) (Procedure)

High Fresh Gas Flow

Active Comparator

Participants will receive general anesthesia with a fresh gas flow rate of 4 L/min during the maintenance phase following an initial fresh gas flow of 4 L/min for 8 minutes after endotracheal intubation. Postoperative lung ultrasonography will be performed 30 minutes after extubation.

Intervention: High Fresh Gas Flow (4 L/min) (Procedure)

Outcomes

Primary Outcomes

Postoperative Lung Ultrasound Score

Time Frame: 30 minutes after extubation

Lung ultrasonography will be performed 30 minutes after extubation. Both lungs will be divided into 12 regions, with 6 regions assessed in each lung. Each region will be scored from 0 to 3: 0 indicates normal aeration with A-lines or fewer than three B-lines; 1 indicates at least three well-spaced B-lines; 2 indicates coalescent B-lines; and 3 indicates lung consolidation. The scores from all regions will be summed, resulting in a total score ranging from 0 to 36. Higher scores indicate greater loss of lung aeration.

Secondary Outcomes

  • Peak airway pressure(Throughout the intraoperative period)
  • Incidence of postoperative atelectasis(30 minutes after extubation)
  • Peripheral oxygen saturation (SpO₂)(During surgery)
  • Mean arterial pressure(During surgery)
  • Heart rate(During surgery)

Investigators

Sponsor
Adiyaman University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

MEHMET DURAN

Assistant Professor

Adiyaman University

Study Sites (1)

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