Effects of Video-Assisted Surgery on Ventilatory Parameters

NCT04513262 | Completed

• 1 other identifier: RAS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Surgery--Complications

Outcome Measures

Primary Outcomes (1)

• lung compliance

  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.

  one-hour and two-hours after induction of pneumoperitoneum

Secondary Outcomes (1)

• arterial to end-tidal CO2 difference

  one-hour and two-hours after induction of pneumoperitoneum

Study Arms (1)

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.

Procedure: mechanical ventilation during video-assisted surgery

Interventions

mechanical ventilation during video-assisted surgery PROCEDURE

observed variation of ventilatory parameters during video-assisted surgery

Video-assisted surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

consecutive patients undergoing video-assisted surgery in a university hospital after inclusion and exclusion criteria have been met. Video-assisted surgery is defined by either classic laparoscopic surgery or robotic assisted surgery and the medical decision between the two types of surgery was performed by the attending surgeon prior to patient inclusion (unrelated to the study).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institutul Clinic Fundeni: lead

Study Sites (1)

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

Study Officials

• Dana Tomescu, Prof

  Fundeni Clinical Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: March 20, 2015
• Primary Completion: November 10, 2018
• Study Completion: November 10, 2018
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)