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

March 24, 2025 updated by: Kimmy Bais, Ohio State University

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-Operative Pulmonary Complications
Time Frame: After surgery until 30 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samuel Lindsey, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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