Low Tidal Volume for Lung Protection During Anesthesia of Laparoscopic Surgery in Trendlenburg Position (lapVent)

September 16, 2015 updated by: AlRefaey Kandeel
Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury. Since lung protective ventilation has been recommended during anesthesia to prevent ongoing lung injury, so in our study the investigators will compare three different lung protective strategies regarding their lung protective effect measured by the incidence of postoperative pulmonary complications, perioperative oxygenation and postoperative inflammatory mediator release.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

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

  • Egypt
    • Dkahleya
      • Mansoura, Dkahleya, Egypt
        • Mansoura University

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients undergoing laparoscopic colorectal or gynaecologic surgery with expected time more than two hours

Exclusion Criteria:

  • refusal, preoperative pulmonary disease

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
mechanical ventilation with Tidal volume 4 ml/kg and PEEP 8-10 cm H2o
Device: mechanical ventilation
Active Comparator: Group2
mechanical ventilation with Tidal volume 6 ml/kg and PEEP 8-10 cm H2o
Device: mechanical ventilation
Active Comparator: Group 3
mechanical ventilation with Tidal volume 8 ml/kg and PEEP 8-10 cm H2o
Device: mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative pulmonary complications
Time Frame: 1 week
1 week

Collaborators and Investigators

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

Sponsor

AlRefaey Kandeel

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

October 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Estimate)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • DrSamah

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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