SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, Bakırkoy, 34147, Turkey (Türkiye)
Location status: Recruiting
Location contact
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NCT Number: NCT07349784
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Istanbul, Bakırkoy, 34147, Turkey (Türkiye)
Location status: Recruiting
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Automated lung recruitment maneuvers will be performed intraoperatively using the anesthesia ventilator in pressure-controlled ventilation mode according to a standardized protocol.
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).
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: From the end of surgery until hospital discharge (up to postoperative day 30).
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 preoperative baseline through postoperative day 1
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: Intraoperatively,immediediately after the first recruitment maneuver(within 10 minutes after the maneuver) and during the early postoperative period (30 minutes after extubation).
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: From postoperative intensive care unit admission until discharge from the intensive care unit (up to 30 days).
The duration of intensive care unit stay will be recorded in days for patients requiring postoperative intensive care admission.
Time frame: From the day of surgery until hospital discharge(up to 30 days)
Total length of hospital stay will be recorded in days from the day of surgery until hospital discharge.
Contact information is provided by the study sponsor or research team.
Evrim Kucur Tülübaş
CONTACT
Sena Gökçe Karataş
CONTACT
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Other Gov
Effect of Automated Intraoperative Lung Recruitment Maneuvers on Atelectasis in Patients Undergoing Major Laparoscopic Surgery: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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