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

NCT ID: NCT02553057

Last Updated: 2015-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Intraoperative Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

mechanical ventilation with Tidal volume 4 ml/kg and PEEP 8-10 cm H2o

Group Type ACTIVE_COMPARATOR

mechanical ventilation

Intervention Type DEVICE

Group2

mechanical ventilation with Tidal volume 6 ml/kg and PEEP 8-10 cm H2o

Group Type ACTIVE_COMPARATOR

mechanical ventilation

Intervention Type DEVICE

Group 3

mechanical ventilation with Tidal volume 8 ml/kg and PEEP 8-10 cm H2o

Group Type ACTIVE_COMPARATOR

mechanical ventilation

Intervention Type DEVICE

Interventions

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mechanical ventilation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* refusal, preoperative pulmonary disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AlRefaey Kandeel

OTHER

Sponsor Role lead

Responsible Party

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AlRefaey Kandeel

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Mansoura university

Al Mansurah, Dkahleya, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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DrSamah

Identifier Type: -

Identifier Source: org_study_id

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