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AzTrials

Pulmonary AtelectasisLUNG USG SCORENCT07324122

Effect of Recruitment Maneuver on Postoperative Atelectasis Assessed by Lung Ultrasound in Laparoscopic Cholecystectomy

A study testing Alveolar recruitment manoeuvre and Lung-protective ventilation with lung ultrasound assessment in people with Pulmonary Atelectasis, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single-centre, prospective, randomized, parallel-group controlled trial evaluated whether alveolar recruitment manoeuvres (RMs) added to a lung-protective ventilation strategy improve perioperative lung aeration in adults undergoing elective laparoscopic cholecystectomy under general anaesthesia. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Atelectasis
What is being tested?
Alveolar recruitment manoeuvre and Lung-protective ventilation with lung ultrasound assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Apr 2025to 26 Oct 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Age between 18 and 75 years
  • Body mass index (BMI) < 30 kg/m²
  • American Society of Anesthesiologists (ASA) physical status classification I-III
  • Provision of written informed consent

Who cannot join

  • Refusal to participate in the study
  • Emergency surgical procedures
  • Body mass index (BMI) ≥ 30 kg/m²
  • American Society of Anesthesiologists (ASA) physical status classification IV

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

    Istanbul, Istanbul, 34000

Other trials in Turkey (Türkiye)

About this study

Official title: EVALUATION OF THE EFFECT OF RECRUITMENT MANEUVER ON POSTOPERATIVE ATELECTASIS IN LAPAROSCOPIC CHOLECYSTECTOMY SURGERY USING LUS (LUG ULTRASOUND SCALE)

This single-centre, prospective, randomized, parallel-group controlled trial evaluated whether alveolar recruitment manoeuvres (RMs) added to a lung-protective ventilation strategy improve perioperative lung aeration in adults undergoing elective laparoscopic cholecystectomy under general anaesthesia. Eighty patients (ASA I-III) were allocated 1:1 to an RM group or a control group. Both groups received identical low-tidal-volume ventilation with 5 cmH₂O PEEP; the RM group additionally received a standardized stepwise recruitment manoeuvre at two points-after establishment of pneumoperitoneum and again before extubation-with PEEP returned to 5 cmH₂O after each manoeuvre. Lung aeration was assessed by an 8-zone lung ultrasound (LUS) protocol at five predefined perioperative time points. The primary outcome was the perioperative composite LUS score trajectory. Peripheral oxygen saturation, mean arterial pressure, and heart rate were assessed as safety outcomes.

Read the detailed description

Laparoscopic cholecystectomy under general anaesthesia with CO₂ pneumoperitoneum predictably reduces lung aeration and promotes atelectasis that global monitoring parameters may fail to detect. This trial compared two intraoperative ventilation strategies differing solely in the application of alveolar recruitment manoeuvres, using serial lung ultrasound to quantify regional aeration.

Adults aged 18-75 years, ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy were eligible. Patients undergoing emergency surgery, with severe pre-existing pulmonary disease (e.g., COPD GOLD stage ≥ III, interstitial lung disease) or previous thoracic surgery, who were pregnant, or who required conversion to open surgery were excluded. Eligible participants were randomized 1:1 using a computer-generated sequence, with allocation concealed by sequentially numbered, sealed, opaque envelopes.

All patients received standardized general anaesthesia and volume-controlled ventilation (tidal volume 6-8 mL/kg predicted body weight, PEEP 5 cmH₂O, FiO₂ titrated to SpO₂ ≥ 95%, EtCO₂ 35-40 mmHg). In the RM group, a standardized stepwise recruitment manoeuvre (driving pressure 15 cmH₂O; PEEP incremented 5 → 10 → 15 cmH₂O in 10-15-second steps) was performed twice: first immediately after establishment of CO₂ pneumoperitoneum and surgical positioning, and second after pneumoperitoneum deflation and before extubation. PEEP was returned to 5 cmH₂O after each manoeuvre, identical to the control group, so that the groups differed only by the recruitment manoeuvres and not by sustained PEEP. The control group received no recruitment manoeuvre, with PEEP maintained at 5 cmH₂O throughout. Intra-abdominal pressure was limited to 12 mmHg.

An 8-zone LUS protocol (each hemithorax divided into anterior-upper, anterior-lower, lateral-upper, and lateral-lower regions) was applied at five predefined time points: T1, preoperative baseline; T2, 5 minutes after induction; T3, after pneumoperitoneum establishment and the first recruitment manoeuvre; T4, immediately after extubation and the second recruitment manoeuvre; and T5, 30 minutes after arrival in the post-anaesthesia care unit. LUS examinations were performed by a dedicated team of blinded anaesthesiology specialists independent of intraoperative ventilation management.

The primary outcome was the perioperative composite LUS score trajectory across the five time points, analysed with a linear mixed-effects model (group, time, and group × time interaction). Safety outcomes were peripheral oxygen saturation, mean arterial pressure, and heart rate at each time point.

Being tested
Alveolar recruitment manoeuvre, Lung-protective ventilation with lung ultrasound assessment
Keywords
Protective lung ventilation, Laparoscopic surgery, Alveolar recruitment, Pneumoperitoneum, Cholecystectomy, Perioperative respiratory complications, Lung ultrasound score, Lung ultrasound, LUS
Medical subject headings
Pulmonary Atelectasis, Pneumoperitoneum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alveolar recruitment manoeuvreProcedure or surgery

    A standardized stepwise alveolar recruitment manoeuvre applied at two intraoperative time points: after establishment of CO₂ pneumoperitoneum and again before extubation. Each manoeuvre uses a fixed driving pressure of 15 cmH₂O with PEEP incremented stepwise (5 → 10 → 15 cmH₂O, 10-15 seconds per step), then PEEP returned to 5 cmH₂O. The manoeuvre is terminated if peak inspiratory pressure exceeds 35 cmH₂O or haemodynamic instability occurs. Applied in addition to low-tidal-volume protective ventilation.

  • Lung-protective ventilation with lung ultrasound assessmentProcedure or surgery

    Volume-controlled low-tidal-volume ventilation (6-8 mL/kg predicted body weight) with 5 cmH₂O PEEP and FiO₂ titrated to maintain SpO₂ ≥ 95%, applied to both groups. Perioperative lung aeration is assessed using a standardized 8-zone lung ultrasound protocol at five predefined time points (preoperative baseline, 5 minutes post-induction, post-pneumoperitoneum, immediately post-extubation, and 30 minutes after PACU arrival) by blinded assessors independent of ventilation management.

Study groups in NCT07324122
Study groupRoleWhat they receive
Recruitment manoeuvre (RM) groupExperimentalPatients receive low-tidal-volume ventilation (6-8 mL/kg predicted body weight) with 5 cmH₂O PEEP, plus a standardized stepwise alveolar recruitment manoeuvre applied at two time points: after establishment of CO₂ pneumoperitoneum and again before extubation. Each manoeuvre uses a fixed driving pressure of 15 cmH₂O with PEEP incremented stepwise (5 → 10 → 15 cmH₂O, 10-15 seconds per step); PEEP is returned to 5 cmH₂O after each manoeuvre. Lung aeration is assessed by 8-zone lung ultrasound at five predefined perioperative time points.
Receives: Procedure: Alveolar recruitment manoeuvre
Control group (no recruitment manoeuvre)Active comparatorPatients receive low-tidal-volume ventilation (6-8 mL/kg predicted body weight) with 5 cmH₂O PEEP maintained throughout the intraoperative period, without any alveolar recruitment manoeuvre. All other anaesthetic and surgical management is identical to the RM group. Lung aeration is assessed by 8-zone lung ultrasound at the same five predefined perioperative time points.
Receives: Procedure: Lung-protective ventilation with lung ultrasound assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Lung Ultrasound Score (LUS)

    Lung ultrasound score (LUS) assessed using a 8-zone scanning technique. Each zone is scored from 0 (normal aeration, A-lines) to 3 (lung consolidation). Total score ranges from 0 to 36, with higher scores indicating worse lung aeration. Change calculated as difference from baseline (T0) to T1 and T2.

    Measured: Baseline (T0), 30 minutes after pneumoperitoneum (T1), and 30 minutes after desufflation (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start25 Apr 2025
  3. Primary completion25 Oct 2025
  4. Study completion26 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm parallel-group randomized controlled trial. Eligible patients were allocated 1:1 to a recruitment manoeuvre group or a control group using a computer-generated randomization sequence with allocation concealment by sequentially numbered, sealed, opaque envelopes. Both groups received identical low-tidal-volume ventilation with 5 cmH₂O PEEP; the groups differed only by the application of standardized alveolar recruitment manoeuvres in the intervention group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07324122
Sponsor's protocol ID
FSMTRHLUS
Other IDs
2025-KAEK-43
Acronym
LUNG USG SCORE
Status last verified
Jul 2026
First submitted
24 Dec 2025
Last updated
5 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared.

Publications

  • Liu Y, Wang J, Geng Y, Zhang Y, Su H, Yang Y. The effect of ultrasound-guided lung recruitment maneuvers on atelectasis in lung-healthy patients undergoing laparoscopic gynecologic surgery: a randomized controlled trial. BMC Anesthesiol. 2022 Jul 1;22(1):200. doi: 10.1186/s12871-022-01742-1.

    PubMed 35778701
  • Kim BR, Lee S, Bae H, Lee M, Bahk JH, Yoon S. Lung ultrasound score to determine the effect of fraction inspired oxygen during alveolar recruitment on absorption atelectasis in laparoscopic surgery: a randomized controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):173. doi: 10.1186/s12871-020-01090-y.

    PubMed 32682397

Questions about this trial

What is this clinical trial studying?

A study testing Alveolar recruitment manoeuvre and Lung-protective ventilation with lung ultrasound assessment in people with Pulmonary Atelectasis, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lung Ultrasound Score (LUS) (time frame: Baseline (T0), 30 minutes after pneumoperitoneum (T1), and 30 minutes after desufflation (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07324122, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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