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

Intraoperative Ventilation Management and Postoperative Pulmonary Complications in Patients at High Risk for Obstructive Sleep Apnea

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ventilator-Induced Lung Injury

Detailed Description

LPV was first introduced in the intensive care units but has been recently adopted in the operating rooms. Obstructive sleep apnea (OSA) is a widely prevalent condition in obese patients and requires special attention in the operating room. Screening for OSA risk in surgical patients is a common practice. The STOP-BANG questionnaire is a common screening tool for OSA (Snoring, Tiredness, Observed apnea, high blood Pressure, BMI, Age, Neck circumference, and male Gender). The American Society of Anesthesiologists practice guidelines for the perioperative management of patients with OSA do not recommend any specific ventilation strategy to prevent PPCs in this population. To the knowledge of the investigators, the association between intraoperative ventilation strategies and PPCs in laparoscopic bariatric surgery patients, who have a high STOP-BANG score, has not been adequately investigated. The investigators propose a retrospective chart review of 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, 2012 and November 22, 2016, to determine whether intraoperative driving pressure is a predictor of postoperative pulmonary complications. No procedures will be done for the sake of conducting this study except for a retrospective review of patient charts. Preoperative and intraoperative variables will be collected to determine their predictive value of postoperative complications. No risks to the patients' health or well being are anticipated due to the conduct of the proposed study. No immediate benefits to the patients from whom data was collected is anticipated either. Results obtained from this study may provide valuable information on the preferred ventilation strategies in the operating room for future patients who have a high risk of postoperative lung complications.

• Study Type: Observational
• Enrollment (Estimated): 2636

Contacts and Locations

• Study Contact: Name: Samuel Lindsey, MD; Phone Number: 614-293-8487; Email: samuel.lindsey@osumc.edu
• Study Contact Backup: Name: Juan Fiorda, MD, PhD; Phone Number: 614-293-3559; Email: juan.fiorda@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Samuel Lindsey, MD, The Ohio State University Wexner Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: 2016H0423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No