Low Tidal Volume for Lung Protection During Anesthesia of... | NCT02553057

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

NCT02553057

Sponsor

AlRefaey Kandeel

Status

Unknown status

Last Update Posted

Sep 17, 2015Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Intraoperative Mechanical Ventilation

Interventions

mechanical ventilation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Sep 15, 2015

First Submission Date that Met QC Criteria

Sep 16, 2015

First Posted Date

Sep 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2015

Last Update Posted Date

Sep 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
mechanical ventilation	Device		Group 1 Group 3 Group2

Measure	Description	Time Frame
postoperative pulmonary complications		1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

refusal, preoperative pulmonary disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university		Al Mansurah	Dkahleya		Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D012121	Respiration, Artificial

Ancestor Terms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D012151	Resuscitation
D004638	Emergency Treatment

Browse Leaves

Not provided

Browse Branches

Not provided