Ankara University Faculty of Medicine
Ankara, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07662642
Robotic prostate surgery is commonly performed under general anesthesia with carbon dioxide pneumoperitoneum and steep Trendelenburg positioning. These conditions may reduce lung volumes, impair respiratory mechanics, and increase the risk of atelectasis and postoperative pulmonary complications. Recruitment maneuvers combined with individualized positive end-expiratory pressure may improve intraoperative oxygenation and lung compliance; however, the optimal timing of recruitment maneuver application in robotic prostate surgery remains unclear.
This prospective randomized study aims to compare the effects of recruitment maneuver timing on postoperative pulmonary complications in adult patients undergoing elective robotic prostate surgery. Participants will be randomized into two groups. In the Supine Recruitment Group, the recruitment maneuver will be performed before carbon dioxide insufflation while the patient is in the supine position, followed by individualized PEEP determination. In the Trendelenburg Recruitment Group, the recruitment maneuver will be performed after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination. Patients will be evaluated for postoperative pulmonary complications up to postoperative 72 hours or until discharge, whichever occurs first.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Ankara, Turkey (Türkiye)
Location status: Recruiting
Laparoscopic and robotic surgeries performed with carbon dioxide insufflation may cause clinically relevant physiological changes affecting pulmonary function. Pneumoperitoneum increases intra-abdominal pressure and, together with Trendelenburg positioning, may reduce functional residual capacity, decrease lung compliance, and promote atelectasis. These changes may contribute to hypoxemia and postoperative pulmonary complications.
Recruitment maneuvers are used to reopen collapsed alveolar units and may improve oxygenation and respiratory mechanics when combined with appropriate PEEP. Decremental PEEP titration is one method used to determine an individualized PEEP level after a recruitment maneuver by gradually reducing PEEP while monitoring oxygenation, respiratory compliance, and hemodynamic parameters.
The present study will evaluate whether the timing of recruitment maneuver application affects postoperative pulmonary outcomes in patients undergoing robotic prostate surgery. The study will compare recruitment maneuver performed before insufflation in the supine position with recruitment maneuver performed after insufflation and Trendelenburg positioning. Both groups will undergo individualized PEEP determination after the recruitment maneuver.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A lung recruitment maneuver will be applied after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination using decremental PEEP titration.
The recruitment maneuver will be performed while the patient is in the supine position, before pneumoperitoneum insufflation and Trendelenburg positioning during robotic prostate surgery. The maneuver will be applied according to the predefined intraoperative ventilation protocol to improve alveolar recruitment and reduce postoperative pulmonary complications.
Time frame: From the end of surgery to postoperative 72 hours or until hospital discharge, whichever occurs first.
Postoperative pulmonary complications will be evaluated after surgery, including clinically relevant pulmonary events such as atelectasis, hypoxemia, respiratory infection, bronchospasm, aspiration pneumonitis, respiratory failure, need for noninvasive or invasive ventilatory support, or other predefined pulmonary complications according to the study protocol.
Time frame: From the day of surgery to hospital discharge, assessed up to 30 days.
Duration of hospital stay will be recorded in days from the day of surgery to hospital discharge.
Time frame: Intraoperative period
Respiratory system compliance will be recorded during mechanical ventilation at predefined intraoperative time points.
Ankara University
Other
Comparison of the Effects of Recruitment Maneuver Timing on Postoperative Pulmonary Complications in Patients Undergoing Robotic Prostate Surgery
Acronym: ROBPROREC1
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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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