Ventilator-Induced Lung InjuryNCT03135691
Intraop Ventilation Management and Postop Pulmonary Complications in High Risk Patients for OSA
An observational study of Ventilator-Induced Lung Injury, run by Ohio State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Induced Lung Injury
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2017to 24 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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).
Read the 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.
- Conditions
- Ventilator-Induced Lung Injury
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After surgery until 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start18 Jan 2017
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Why it stopped: unable to retrieve data from EMR.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimmy Bais, Ohio State University
- Investigators
- Samuel Lindsey, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135691
- Sponsor's protocol ID
- 2016H0423
- Status last verified
- Mar 2025
- First submitted
- 30 Jan 2017
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Ventilation Management and Postoperative Pulmonary Complications in Patients at High Risk for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03135691
- Acronym / sponsor ID
- 2016H0423
- Conditions
- Ventilator-Induced Lung Injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: unable to retrieve data from EMR.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung protective ventilation (LPV) has been proposed to reduce the incidence of postoperative pulmonary complications (PPCs), and protect against ventilator induced lung injury (VILI).
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at High Risk for OSA | – | –Patients at High Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Bariatric Surgery; retrospective study, no intervention administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Lindsey, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Induced Lung Injury, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Operative Pulmonary Complications (time frame: After surgery until 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.