Recruiting

Airway Interventions

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT01495936

Conditions

Thoracic, Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RM + Positive End Expiratory Pressure

Continuous Positive Airway Pressure

Study Details

Brief 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:

1. Continuous Positive Airway Pressure (CPAP) applied to the non ventilated (non breathing) lung and
2. 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.

Conditions

Thoracic, Diseases

Study ID

NCT01495936

Start date

Oct 17, 2011

Status verified date

Nov, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 or older
2. Competent to give consent to enroll in study
3. Booked for scheduled open thoracotomy which involves wedge resection, lobectomy or pneumonectomy requiring OLV
4. American Society of Anesthesia physical status score (ASA) 1-4

Exclusion Criteria:

1. Unable to give consent
2. Pregnant women
3. Inability to insert an arterial line
4. Presence of other significant pulmonary impairment (PaO2 on room air <50mmHg, PaCO2 >50mmHg or known pulmonary hypertension (mean PAP>25mmHg)
5. Presence of significant cardiovascular disease
6. Altered liver function (Child Pugh scale ≥B)
7. Patients with bullous lung disease. -

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Continuous Positive Airway Pressure

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.

active comparator: RM + Positive End Expiratory Pressure

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.

Interventions

RM + Positive End Expiratory Pressure

A recruitment maneuver (RM) will be applied to the ventilated lung by performing a valsalva maneuver for 5 seconds (holding the inspiratory pressure at 25cmH2O). Immediately after the RM, Positive End Expiratory Pressure (PEEP) will be applied to the ventilated lung at a pressure of 5cmH2O for 20 minutes. Both the RM and PEEP will be performed using the operating room ventilator.

Continuous Positive Airway Pressure

Continuous positive airway pressure, at a pressure of 5cmH2O will applied to the non-ventilated lung for 20 minutes by the Mallinckrodt Bronchocath Disposable CPAP system (a recognised anesthetic breathing system design for CPAP)

Primary outcome measure

  • Partial pressure of oxygen in blood [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Neal Badner, MD, FRCP (C)

519 685 8500Neal.Badner@lhsc.on.ca

George Nicolaou, MD, FRCP (C)

519 685 8500George.Nicolaou@lhsc.on.ca

Locations

Victoria Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Nov 6, 2017

Last verified

Nov, 2017

Keywords

  • One Lung Ventilation (OLV)
  • Continuous Positive Airway Pressure (CPAP)
  • Positive End Expiratory Pressure (PEEP)
  • Lung recruitment maneuver
  • Hypoxia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2017-11-06.