Fresh Gas Flow and Lung Ultrasonography in Laparoscopic Cholecystectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAdiyaman University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Low Fresh Gas Flow (0.5 L/min)
Procedure/SurgeryGeneral anesthesia will be maintained using a fresh gas flow rate of 0.5 L/min after an initial fresh gas flow of 4 L/min for 8 minutes following endotracheal intubation.
High Fresh Gas Flow (4 L/min)
Procedure/SurgeryGeneral anesthesia will be maintained using a fresh gas flow rate of 4 L/min after an initial fresh gas flow of 4 L/min for 8 minutes following endotracheal intubation.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Low Fresh Gas FlowActive comparator 1 intervention
Group B: High Fresh Gas FlowActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Lung Ultrasound Score
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.
Time frame
30 minutes after extubationSecondary outcomes
1
Incidence of postoperative atelectasis
Atelectasis will be defined as a consolidation score ≥2 in any lung region assessed by lung ultrasonography
Time frame
30 minutes after extubation2
Peripheral oxygen saturation (SpO₂)
Time frame
During surgery3
Mean arterial pressure
Time frame
During surgery4
Heart rate
Time frame
During surgerySponsors and contacts
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Source ClinicalTrials.gov
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