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

Intraoperative Mechanical Ventilation Clinical Trial

— lapVent  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02553057
• Other study ID #: DrSamah
• Status: Not yet recruiting
• Phase: N/A
• First received: September 15, 2015
• Last updated: September 16, 2015
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• refusal, preoperative pulmonary disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intraoperative Mechanical Ventilation

Intervention

Device:
• mechanical ventilation

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura	Dkahleya

Sponsors (1)

Lead Sponsor	Collaborator
AlRefaey Kandeel

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pulmonary complications		1 week	Yes