Effects of Video-Assisted Surgery on Ventilatory Parameters

Completed

• Conditions: Surgery--Complications
• Interventions: Procedure: mechanical ventilation during video-assisted surgery

• Registration Number: NCT04513262
• Lead Sponsor: Institutul Clinic Fundeni

Brief Summary

The study investigates the effects of induced pneumoperitoneum during surgery on ventilatory parameters including peak inspiratory pressure, lung compliance, end-tidal CO2 at specific time-points: after induction of anaesthesia, after induction of surgery, one-hour and two-hours during surgery, end of surgery.

The effects of pneumoperitoneum are compared between two groups of patients: patients undergoing laparoscopic surgery and patients undergoing robotic-assisted surgery. No intervention was performed in this study and the decision for type of surgery performed was made by the attending surgeon prior to study inclusion

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-20
• Primary Completion: 2018-11-10
• Study Completion: 2018-11-10
• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Study First Posted: 2020-08-14
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients who underwent video-assisted surgery by either classic laparoscopy or robotic-assisted surgery.

Exclusion Criteria

• refusal to participate
• conversion of surgery to laparotomy
• need of vasopressure support
• preoperative severe respiratory dysfunction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Video-assisted surgery	mechanical ventilation during video-assisted surgery	Patients undergoing video-assisted major abdominal surgery (VAS) in Trendelenburg position. The decision regarding the type of VAS was made by the attending surgeon prior to study inclusion. Twenty-five consecutive patients undergoing classic laparoscopic surgery and twenty-five patients undergoing robotic-assisted surgery will be included in the study.

Primary Outcome Measures

Name	Time	Method
lung compliance	one-hour and two-hours after induction of pneumoperitoneum	change in lung compliance (mL/cmH2O) before and after induction of pneumoperitoneum in patients undergoing VAS. Lung compliance is automatically calculated by the anesthesia machine during surgery. The study compares the magnitude in change associated with VAS.

Secondary Outcome Measures

Name	Time	Method
arterial to end-tidal CO2 difference	one-hour and two-hours after induction of pneumoperitoneum	difference in arterial to end-tidal CO2 (mmHg) during surgery. Arterial blood samples and end-tidal CO2 were simultanously obtained at the specific time-points.

Trial Locations

Locations (1)

Fundeni Clinical Institute; 🇷🇴 Bucharest, Romania