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Protective Ventilation Strategies for One-Lung Ventilation During Thoracic Surgery

N/A

Waitlist Available

Led By Mert Sentürk

Research Sponsored by Technische Universität Dresden

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)

Planned lung separation with double lumen tube (DLT, not for study purpose only)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Study Summary

This trial is testing whether using higher levels of PEEP and recruitment maneuvers during thoracic surgery can prevent postoperative pulmonary complications better than using lower levels of PEEP without recruitment maneuvers.

Who is the study for?

This trial is for adults with a BMI under 35, undergoing thoracic surgery requiring one-lung ventilation (OLV) that lasts over an hour. Candidates must not have severe heart or lung conditions, previous lung surgeries, need for post-surgery mechanical breathing support, or be pregnant.Check my eligibility

What is being tested?

The study tests if using higher levels of PEEP (a type of pressure applied by ventilators) and recruitment maneuvers during OLV can prevent complications after thoracic surgery better than lower PEEP without these maneuvers.See study design

What are the potential side effects?

Potential side effects may include discomfort from the increased pressure in the lungs due to high PEEP and possible transient low oxygen levels or barotrauma (injury caused by increased air pressure) from recruitment maneuvers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a planned lung surgery with general anesthesia.

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I am scheduled for a procedure that involves separating my lungs using a double lumen tube.

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My surgery is expected to last more than an hour.

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My surgery will mostly use one-lung ventilation.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of patients developing one or more postoperative pulmonary complications

Trial Design

2Treatment groups

Experimental Treatment

Group I: THE LOWER PEEP LEVELExperimental Treatment1 Intervention

Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 5 cmH2O without lung recruitment maneuvers

Group II: THE HIGHER PEEP LEVELExperimental Treatment2 Interventions

Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 10 cmH2O with lung recruitment maneuvers

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PEEP level

2018

N/A

~40

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

European Society of Anaesthesiology and Intensive CareUNKNOWN

7 Previous Clinical Trials

15,518 Total Patients Enrolled

Technische Universität DresdenLead Sponsor

282 Previous Clinical Trials

2,269,455 Total Patients Enrolled

Istanbul UniversityOTHER

437 Previous Clinical Trials

65,068 Total Patients Enrolled

Media Library

PEEP level Clinical Trial Eligibility Overview. Trial Name: NCT02963025 — N/A

One Lung Ventilation Research Study Groups: THE LOWER PEEP LEVEL, THE HIGHER PEEP LEVEL

One Lung Ventilation Clinical Trial 2023: PEEP level Highlights & Side Effects. Trial Name: NCT02963025 — N/A

PEEP level 2023 Treatment Timeline for Medical Study. Trial Name: NCT02963025 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can potentially take part in this research?

"Affirmative. According to the data on clinicaltrials.gov, this medical trial - which was first published in January 2017 and most recently amended in June 2022 - is actively enrolling patients. The study requires 2378 individuals from 2 different sites."

Answered by AI

Are additional participants still being enrolled in this research initiative?

"Affirmative. According to information found on clinicaltrials.gov, this medical trial has been recruiting since January 1st 2017 and the last update was made on June 1st 2022. A total of 2378 people are needed for the study at two separate sites."

Answered by AI

Recent research and studies

TrialsJournal

Protective Ventilation with High Versus Low Positive End-expiratory Pressure During One-lung Ventilation for Thoracic Surgery (PROTHOR): Study Protocol for a Randomized Controlled Trial

Kiss, T., for the PROTHOR investigators, J. Wittenstein, C. Becker, K. Birr, G. Cinnella, E. Cohen, et al.. 2019. “Protective Ventilation with High Versus Low Positive End-expiratory Pressure During One-lung Ventilation for Thoracic Surgery (PROTHOR): Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-019-3208-8.

clinicaltrials.govStudy

Protective Ventilation With High Versus Low PEEP During One-lung Ventilation for Thoracic Surgery

2017. "Protective Ventilation With High Versus Low PEEP During One-lung Ventilation for Thoracic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02963025.