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OpenTrials
Completed

NCT Number: NCT04513262

Effects of Video-Assisted Surgery on Ventilatory Parameters

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

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Key information

Conditions

Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundeni Clinical Institute

Bucharest, 022328, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mechanical ventilation during video-assisted surgery

Procedure

observed variation of ventilatory parameters during video-assisted surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institutul Clinic Fundeni

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2020
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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