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RM + Positive End Expiratory Pressure for Thoracic Diseases

N/A
Waitlist Available
Led By Neal Badner, MD FRCP (C)
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights

Study Summary

Patients requiring one lung ventilation (OLV) for open thoracic surgery will be ventilated (breathing performed by a breathing machine) during anesthesia using a lung protective ventilation strategy (small breath volumes at 6ml/kg). During thoracic surgery the anesthesiologist is able to ventilate only one lung by inserting a special breathing tube, allowing the surgeon to operate on the non ventilated (diseased) lung. In a randomized trial two interventions used to improve blood oxygen levels during one lung ventilation will be compared . The two interventions are: Continuous Positive Airway Pressure (CPAP) applied to the non ventilated (non breathing) lung and Positive End Expiratory Pressure following a lung Recruitment Maneuver (RM-PEEP) to the ventilated (breathing) lung. CPAP is performed by applying a steady flow of oxygen to the non ventilated (non breathing) lung at a continuous gentle pressure of 5cmH20. To perform a Recruitment Maneuver (RM) the anesthesiologist inflates the ventilated (breathing) lung with oxygen, holding the breath for 25 seconds so all the lung is opened up. Immediately after the recruitment maneuver PEEP will be applied. PEEP is an action which also helps keep the lung open, maintaining the benefits achieved by the RM. It is performed by adjusting settings on the ventilator (breathing machine). The ventilator creates and applies a gentle pressure (5cmH20) to the ventilating lung at the end of each breath. The outcome measure will be the oxygen content in blood (PaO2), measured in mmHg, using blood sample analysis. The null hypothesis is that compared to CPAP, RM-PEEP does not significantly increase the oxygen content of blood during OLV when using a lung protective ventilation strategy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Partial pressure of oxygen in blood
Secondary outcome measures
Hypoxia
Hypoxia intervention techniques

Trial Design

2Treatment groups
Active Control
Group I: RM + Positive End Expiratory PressureActive Control1 Intervention
After 20 minutes of ventilation on one lung (during anesthesia) the patient will be randomly assigned to the study arm "RM + Positive End Expiratory pressure" which is a Recruitment Maneuver (RM) followed by Positive End Expiratory Pressure (RM-PEEP) which will be applied to the ventilating lung at a pressure of 5cmH2O.
Group II: Continuous Positive Airway PressureActive Control1 Intervention
After 20 minutes ventilation on one lung (during anesthesia) the patient will be randomly assigned to the study arm "Continuous Positive Airway Pressure (CPAP)". CPAP will be applied for 20 minutes to the non-ventilated lung at a pressure of 5cmH20 using the disposable Mallinckrodt Bronchocath CPAP system.

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Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
662 Previous Clinical Trials
413,930 Total Patients Enrolled
Neal Badner, MD FRCP (C)Principal InvestigatorLawson Health Research Institute

Frequently Asked Questions

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~3 spots leftby May 2025