Effects of Video-Assisted Surgery on Ventilatory Parameters

August 12, 2020 updated by: Popescu Mihai, Institutul Clinic Fundeni

Effects of Pneumoperitoneum on Ventilatory Parameters in Patients Undergoing Video-assisted Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
observed variation of ventilatory parameters during video-assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lung compliance
Time Frame: 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.
one-hour and two-hours after induction of pneumoperitoneum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial to end-tidal CO2 difference
Time Frame: 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.
one-hour and two-hours after induction of pneumoperitoneum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institutul Clinic Fundeni

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2015

Primary Completion (Actual)

November 10, 2018

Study Completion (Actual)

November 10, 2018

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • RAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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