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Enrolling By Invitation
NCT07277244
Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study
Conditions: Robotic Surgery, Post Operative Pulmonary Complications
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Beth Israel Deaconess Medical Center
Location: Beth Israel Deaconess Medical Center Boston Massachusetts
Summary
The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. The feasibility of this ventilation bundle will also be assessed.
Eligibility Criteria
Inclusion Criteria:
* Adult patients undergoing non-emergent intra-abdominal or pelvic robot-assisted surgery with an expected duration of at least 2 hours, under general anesthesia with planned extubation at the end of the procedure
Exclusion Criteria:
* Known pregnancy
* Pre-existing intubation or tracheostomy
* Contraindications for esophageal manometry: severe midface trauma or recent nasal surgery, esophageal varices, recent gastric or esophageal surgery
* Contraindications for electrical impedance tomography (EIT): inability to place EIT belt, presence of an active electronic implantable device (e.g., pacemaker, ICD)
Source: ClinicalTrials.gov (NCT07277244). StuddyBuddy aggregates publicly available trial information.