NCT02553057

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

September 15, 2015

Last Update Submit

September 16, 2015

Conditions

Intraoperative Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • postoperative pulmonary complications

    1 week

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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

Device: mechanical ventilation

Group2

ACTIVE COMPARATOR

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

Device: mechanical ventilation

Group 3

ACTIVE COMPARATOR

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

Device: mechanical ventilation

Interventions

mechanical ventilationDEVICE
Group 1Group 3Group2

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • refusal, preoperative pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dkahleya, Egypt

Location

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 17, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

EG(1)