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AtelectasisNCT07349784

Automated Intraoperative Lung Recruitment Maneuvers in Major Laparoscopic Surgery

A study testing Automated Intraoperative Lung Recruitment Maneuvers in people with Atelectasis and Postoperative Pulmonary Complications (PPCs), run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Laparoscopic colorectal surgery is associated with an increased risk of intraoperative atelectasis due to pneumoperitoneum, Trendelenburg positioning, and prolonged anesthesia duration. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Automated Intraoperative Lung Recruitment Maneuvers
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteTurkey (Türkiye)
Study dates
13 Dec 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 80 years
  • Scheduled for elective laparoscopic colorectal cancer surgery
  • American Society of Anesthesiologists (ASA) physical status I-III

Who cannot join

  • ASA physical status IV or higher
  • Pregnancy
  • Body mass index (BMI) > 40 kg/m²
  • Severe chronic obstructive pulmonary disease (COPD), GOLD stage III-IV
  • Advanced heart failure with left ventricular ejection fraction <35%
  • Previous thoracic surgery
Show all 10Show fewer
  • Preoperative requirement for supplemental oxygen therapy
  • Refusal or inability to provide informed consent
  • Intraoperative conversion to open surgery
  • Development of significant hemodynamic instability during lung recruitment maneuvers

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sena Gökçe Karataş contact

+90 212 414 71 71

senagokce_96@outlook.com

Evrim Kucur Tülübaş contact

+90 212 414 71 71

kucurevrim@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

    Istanbul, Bakırkoy, 34147

    +90 212 414 71 71

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Automated Intraoperative Lung Recruitment Maneuvers on Atelectasis in Patients Undergoing Major Laparoscopic Surgery: A Randomized Controlled Trial

Laparoscopic colorectal surgery is associated with an increased risk of intraoperative atelectasis due to pneumoperitoneum, Trendelenburg positioning, and prolonged anesthesia duration. Atelectasis developing during surgery may persist into the postoperative period and contribute to postoperative pulmonary complications. Automated lung recruitment maneuvers delivered by modern anesthesia ventilators may offer a standardized method to improve lung aeration and reduce atelectasis. This prospective, randomized, single-center controlled trial aims to evaluate the effect of automated intraoperative lung recruitment maneuvers on atelectasis detected by lung ultrasonography in patients undergoing elective major laparoscopic colorectal cancer surgery. Adult patients will be randomized to receive either automated lung recruitment maneuvers or standard mechanical ventilation without recruitment. Lung ultrasonography will be used to assess atelectasis at predefined perioperative time points. The primary outcome is the incidence of atelectasis detected by lung ultrasound, and secondary outcomes include postoperative pulmonary complications, length of intensive care unit stay, length of hospital stay, and perioperative hemodynamic instability.

Read the detailed description

This study is a prospective, randomized, single-center controlled clinical trial designed to evaluate the effects of automated intraoperative lung recruitment maneuvers on perioperative atelectasis and postoperative pulmonary complications in patients undergoing major laparoscopic colorectal cancer surgery under general anesthesia.

Despite its minimally invasive nature, laparoscopic colorectal surgery is associated with significant perioperative respiratory challenges. Pneumoperitoneum, Trendelenburg positioning, and prolonged operative duration may reduce functional residual capacity, impair respiratory mechanics, and promote intraoperative atelectasis. Atelectasis developing during general anesthesia can persist into the postoperative period and is a major contributor to postoperative pulmonary complications.

Although lung recruitment maneuvers are frequently used to improve lung aeration, manual application lacks standardization and reproducibility. Automated lung recruitment maneuvers delivered by modern anesthesia ventilators may provide a standardized and controlled approach to lung recruitment. Lung ultrasonography is a reliable, bedside, radiation-free imaging modality that allows real-time assessment of lung aeration and detection of atelectasis without the need for patient transport.

After confirmation of eligibility and arrival in the operating room, participants will be randomized in a 1:1 ratio to either an automated lung recruitment maneuver group or a control group receiving standard mechanical ventilation without lung recruitment. Standard intraoperative monitoring will be applied to all patients.

Lung ultrasonography will be used to assess lung aeration and detect atelectasis at predefined perioperative time points, including preoperative baseline assessment, intraoperative evaluation, and postoperative follow-up. Lung ultrasound scores will be used to quantify the degree of aeration loss.

In the intervention group, automated lung recruitment maneuvers will be performed intraoperatively using the anesthesia ventilator according to a standardized protocol. An individualized optimal positive end-expiratory pressure will be determined based on dynamic lung compliance and maintained throughout the surgical procedure. A repeat recruitment maneuver will be applied at the end of surgery after cessation of pneumoperitoneum. The control group will receive standard mechanical ventilation according to institutional practice. Perioperative fluid management will be standardized in both groups using a goal-directed fluid therapy approach.

Postoperative follow-up will include systematic assessment for pulmonary complications. Surgical complications, length of intensive care unit stay, and total hospital length of stay will also be recorded.

The primary outcome of the study is the incidence of atelectasis detected by lung ultrasonography. Secondary outcomes include postoperative pulmonary complications, perioperative hemodynamic instability, length of intensive care unit stay, and length of hospital stay.

This study aims to determine whether automated intraoperative lung recruitment maneuvers assessed using lung ultrasonography can reduce perioperative atelectasis and improve postoperative pulmonary outcomes in patients undergoing major laparoscopic colorectal surgery.

Being tested
Automated Intraoperative Lung Recruitment Maneuvers
Keywords
Lung Ultrasound Score (LUS), Automated Lung Recruitment Maneuvers, Laparoscopic Colorectal Surgery
Medical subject headings
Pulmonary Atelectasis

What participants receive

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

  • Automated Intraoperative Lung Recruitment ManeuversProcedure or surgery

    Automated lung recruitment maneuvers will be performed intraoperatively using the anesthesia ventilator in pressure-controlled ventilation mode according to a standardized protocol.

Study groups in NCT07349784
Study groupRoleWhat they receive
Control GroupNo interventionParticipants assigned to the control group will receive standard intraoperative mechanical ventilation according to institutional practice during general anesthesia for laparoscopic colorectal surgery. No lung recruitment maneuvers will be performed. Perioperative monitoring, anesthetic management, and postoperative care will be standardized and identical to those of the intervention group, except for the application of automated lung recruitment maneuvers.
Automated Recruitment GroupExperimentalParticipants in the intervention group will receive standard intraoperative mechanical ventilation plus automated lung recruitment maneuvers performed by the anesthesia ventilator. The automated recruitment protocol will be applied twice: once after induction of anesthesia and before the initiation of pneumoperitoneum, and once again after pneumoperitoneum is terminated. All other anesthetic management, monitoring, and postoperative care will be identical to the control group.
Receives: Procedure: Automated Intraoperative Lung Recruitment Maneuvers

What is being measured

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

  1. Atelectasis detected by lung ultrasonography

    The presence and severity of atelectasis will be assessed using lung ultrasonography performed with a standardized 12-zone scanning protocol. Lung ultrasound scores (LUS) will be calculated for each zone, and severe atelectasis will be defined as a lung ultrasound score of 2 or 3 in any lung region.Lung ultrasound score (LUS) will be assessed using a standardized 12-zone lung ultrasonography protocol. Each lung zone will be scored from 0 to 3 (0 = normal aeration, 1 = moderate loss of aeration, 2 = severe loss of aeration, 3 = consolidation), resulting in a total score ranging from 0 to 36. Higher LUS values indicate worse lung aeration.

    Measured: Preoperative baseline (before anesthesia induction), intraoperative assessment (after induction and before pneumoperitoneum), early postoperative assessment (30 minutes after extubation), and postoperative day 1 (within 24 hours after surgery).

Secondary outcomes (3)
  1. Postoperative pulmonary complications

    Postoperative pulmonary complications will be defined and classified according to the European Perioperative Clinical Outcome (EPCO) definitions. Complications will include respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia. Each complication will be diagnosed based on predefined EPCO criteria using clinical findings, imaging studies, laboratory results, and the need for respiratory support or therapeutic interventions.Postoperative pulmonary complications will be assessed daily during hospitalization.

    Measured: From the end of surgery until hospital discharge (up to postoperative day 30).

  2. Change in lung ultrasound score (LUS)

    Changes in lung ultrasound score will be evaluated using a standardized 12-zone lung ultrasonography protocol. Lung ultrasound scores will be calculated at predefined perioperative time points, and changes in LUS from baseline to intraoperative and postoperative assessments will be analyzed.Lung ultrasound score (LUS) will be assessed using a standardized 12-zone lung ultrasonography protocol. Each lung zone will be scored from 0 to 3 (0 = normal aeration, 1 = moderate loss of aeration, 2 = severe loss of aeration, 3 = consolidation), resulting in a total score ranging from 0 to 36. Higher LUS values indicate worse lung aeration.

    Measured: From preoperative baseline through postoperative day 1

  3. Oxygenation parameters (PaO₂/FiO₂ ratio)

    Arterial blood gas analyses will be used to assess oxygenation. The PaO₂/FiO₂ ratio will be calculated at predefined perioperative time points to evaluate changes in oxygenation status.

    Measured: Intraoperatively,immediediately after the first recruitment maneuver(within 10 minutes after the maneuver) and during the early postoperative period (30 minutes after extubation).

Timeline

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

  1. First posted20 Jan 2026
  2. Study start13 Dec 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07349784
Sponsor's protocol ID
BakirkoySadiKonukAnesthesia
Status last verified
Nov 2025
First submitted
12 Dec 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared due to privacy regulations and lack of ethics approval for external data sharing

Publications

  • Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011 Sep;39(9):2163-72. doi: 10.1097/CCM.0b013e31821f0522.

    PubMed 21572323
  • Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

    PubMed 25058504
  • Nakahira J, Nakano S, Minami T. Evaluation of alveolar recruitment maneuver on respiratory resistance during general anesthesia: a prospective observational study. BMC Anesthesiol. 2020 Oct 17;20(1):264. doi: 10.1186/s12871-020-01182-9.

    PubMed 33069208
  • Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

    PubMed 28186222
  • Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.

    PubMed 27669555
  • Yu X, Zhai Z, Zhao Y, Zhu Z, Tong J, Yan J, Ouyang W. Performance of Lung Ultrasound in Detecting Peri-Operative Atelectasis after General Anesthesia. Ultrasound Med Biol. 2016 Dec;42(12):2775-2784. doi: 10.1016/j.ultrasmedbio.2016.06.010. Epub 2016 Sep 14.

    PubMed 27639431

Questions about this trial

What is this clinical trial studying?

A study testing Automated Intraoperative Lung Recruitment Maneuvers in people with Atelectasis and Postoperative Pulmonary Complications (PPCs), run by Bakirkoy Dr. Sadi Konuk Research and Training 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Jan 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Sena Gökçe Karataş (+90 212 414 71 71, senagokce_96@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atelectasis detected by lung ultrasonography (time frame: Preoperative baseline (before anesthesia induction), intraoperative assessment (after induction and before pneumoperitoneum), early postoperative assessment (30 minutes after extubation), and postoperative day 1 (within 24 hours after surgery).). 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 NCT07349784, which also lists 6 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 21 Jan 2026.

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