Intraop Ventilation Management and Postop Pulmonary Complications in High Risk Patients for OSA

NCT03135691 | Withdrawn

• 1 other identifier: 2016H0423
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Lung protective ventilation (LPV) has been proposed to reduce the incidence of postoperative pulmonary complications (PPCs), and protect against ventilator induced lung injury (VILI).

Conditions

Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• Post-Operative Pulmonary Complications

  Incidence of any post-operative pulmonary complications up to 30 days after surgery in patients at high risk for OSA undergoing laparoscopic bariatric surgery

  After surgery until 30 days

Study Arms (1)

Patients at High Risk for OSA

Patients at High Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Bariatric Surgery; retrospective study, no intervention administered.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will include patients 18 years of age and older who underwent laparoscopic bariatric surgery, in reverse Trendelenburg position, using pressure controlled ventilation (PCV/PCV-VG) at the Ohio State University Wexner Medical Center, between January 01, 2014 and December 07, 2016.

You may qualify if:

• Male or Female
• Age ≥ 18 y/o
• Patients who underwent laparoscopic bariatric surgery
• Surgery under general anesthesia with endotracheal intubation and pressure controlled mode of ventilation (PCV or PCV-VG)

You may not qualify if:

• Pregnant females, prisoners
• Short procedures: time of mechanical ventilation \< 60 minutes
• Patients who received volume controlled ventilation (VCV) mode
• Patients with past medical history of neuromuscular illnesses, pulmonary hypertension or CHF

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Samuel Lindsey, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: May 1, 2017
• Study Start: January 18, 2017
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)