Automated Intraoperative Lung Recruitment Maneuvers in Major Laparoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years
Scheduled for elective laparoscopic colorectal cancer surgery
American Society of Anesthesiologists (ASA) physical status I-III
Disqualifiers
ASA physical status IV or higher
Pregnancy
Body mass index (BMI) > 40 kg/m²
Severe chronic obstructive pulmonary disease (COPD), GOLD stage III-IV
Trial design
Design model
Parallel
Treatments tested in this trial
Automated Intraoperative Lung Recruitment Maneuvers
Procedure/SurgeryAutomated lung recruitment maneuvers will be performed intraoperatively using the anesthesia ventilator in pressure-controlled ventilation mode according to a standardized protocol.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Automated Recruitment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
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).Secondary outcomes
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.
Time frame
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.
Time frame
From preoperative baseline through postoperative day 13
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.
Time frame
Intraoperatively,immediediately after the first recruitment maneuver(within 10 minutes after the maneuver) and during the early postoperative period (30 minutes after extubation).Other outcomes
1
Length of intensive care unit stay
The duration of intensive care unit stay will be recorded in days for patients requiring postoperative intensive care admission.
Time frame
From postoperative intensive care unit admission until discharge from the intensive care unit (up to 30 days).2
Length of hospital stay
Total length of hospital stay will be recorded in days from the day of surgery until hospital discharge.
Time frame
From the day of surgery until hospital discharge(up to 30 days)Sponsors and contacts
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Source ClinicalTrials.gov