A Study to Evaluate Protective Ventilation with High versus Low PEEP During One-lung Ventilation for Thoracic Surgery
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-010977
NCT ID: NCT02963025
Sponsor Protocol Number: EK 392092016
About this study
The purpose of this study is to compare a strategy using high PEEP (10 cmH2O) with recruitment maneuvers versus low PEEP (5 cmH2O) without recruitment maneuvers, during thoracic surgery under standardized one lung ventilation with low VT (5 mL/kg predicted body weight – PBW) in adults.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery).
- BMI < 35 kg/m^2 .
- Age ≥ 18 years old.
- Expected duration of surgery > 60 min.
- Planned lung separation with double lumen tube (DLT, not for study purpose only).
- Most of ventilation time during surgery expected to be in OLV.
Exclusion Criteria:
- COPD GOLD grades III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax.
- Uncontrolled asthma.
- Heart failure NYHA Grade 3 and 4, Coronary Heart Disease CCS Grade 3 and 4.
- Previous lung surgery.
- Documented pulmonary arterial hypertension > 25mmHg MPAP at rest or > 40 mmHg syst. (estimated by ultrasound).
- Documented or suspected neuromuscular disease (thymoma, myasthenia, myopathies, muscular dystrophies, others).
- Planned mechanical ventilation after surgery.
- Bilateral procedures.
- Lung separation with other method than DLT (e.g., difficult airway, tracheostomy).
- Surgery in prone position.
- Persistent hemodynamic instability, intractable shock.
- Intracranial injury or tumor.
- Enrollment in other interventional study or refusal of informed consent.
- Pregnancy (excluded by anamnesis and/or laboratory analysis).
- Eophagectomy, pleural surgery only, sympathectomy surgery only, chest wall surgery only, mediastinal surgery only, lung transplantation.
- Presence before induction of anaesthesia of one of the adverse events, listed as postoperative pulmonary complications (aspiration, moderate respiratory failure, infiltrates, pulmonary infection, atelectasis, cardiopulmonary edema, pleural effusion, pneumothorax, pulmonary embolism, purulent pleuritis, lung hemorrhage.
- Documented preoperative hypercapnia > 45mmHg (6kPa).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Archer Martin, M.D. |
Closed for enrollment |
|
More information
Publications
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Postoperative pulmonary complications (PPC) may result in longer duration of in-hospital stay and even mortality. Both thoracic surgery and intraoperative mechanical ventilation settings add considerably to the risk of PPC. It is unclear if one-lung ventilation (OLV) for thoracic surgery with a strategy of intraoperative high positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) reduces PPC, compared to low PEEP without RM.
Read More on PubMed