Evaluation of Ventilatory Strategies During Laparoscopic Surgery

January 17, 2014 updated by: Emilpaolo Manno, Maria Vittoria Hospital

Re-expansion of Atelectasis During Laparoscopic Surgery. Recruitment Maneuver vs Positive End-expiratory Pressure: a Randomized Study

Atelectasis involving declive areas often occurs during general anesthesia and may persist postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress Index (SI), during constant flow inflation can lead ventilator setting during general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

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

  • Italy
      • Turin, Italy, 10149
        • Maria Vittoria Hospital

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Society Anesthesiology (ASA) I, II;
  • age > 18 years;
  • elective surgery

Exclusion Criteria:

  • ASA III, IV;
  • Age < 18 years;
  • emergency surgery

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients ventilated with zero end expiratory pressure (ZEEP)
patients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure
Procedure: First arm: patients ventilated with zero end expiratory pressure
Active Comparator: Patients ventilated with positive end expiratory pressure
patients undergoing gynecologic laparoscopic surgery ventilated at PEEP
Procedure: Patients ventilated with Positive End Expiratory Pressure
Active Comparator: recruitment plus PEEP
patients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP
Procedure: Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary Stress Index
Time Frame: Continuous evaluation during time of surgery. Partecipants will be followed for the duration of hospital stay, an expected average of 1 weeks
Continuous evaluation during time of surgery. Partecipants will be followed for the duration of hospital stay, an expected average of 1 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac Index
Time Frame: Continuous evaluation during the time of surgery
Continuous evaluation during the time of surgery

Other Outcome Measures

Outcome Measure
Time Frame
Blood gases
Time Frame: Continuous evaluation during the time of surgery
Continuous evaluation during the time of surgery

Collaborators and Investigators

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

Sponsor

Maria Vittoria Hospital

Investigators

  • Study Director: Emilpaolo Manno, MD, Maria Vittoria Hospital

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

November 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCB232
  • MariaVittoria Hospital (Other Identifier: MariaVittoria Hospital)

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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