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The Effect of Two Airway Interventions, During One Lung Ventilation, on Blood Oxygen Content

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Lawson Health Research Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Neal Badner, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01495936
First received: December 16, 2011
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Thoracic, Diseases
Procedure: RM + Positive End Expiratory Pressure
Procedure: Continuous Positive Airway Pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Influence Of Continuous Positive Airway Pressure and Positive End-Expiratory Pressure, With A Recruitment Maneuver, On Oxygenation During One Lung Ventilation Employing A Lung Protective Ventilation Strategy.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Partial pressure of oxygen in blood [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Time 0 (the patient is anesthetized and being ventilated on two lungs, just prior to the commencement of one lung ventilation). Time 20 minutes (patient has been ventilated on one lung for 20 minutes and immediately prior to instituting one of the two intervention arms). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or RM-PEEP]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or RM-PEEP])


Secondary Outcome Measures:
  • Hypoxia [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The incidence of hypoxia (oxygen saturation falling below 90%, measured by pulse oximetry) throughout the entire study period will be recorded and correlated with the study stage.

  • Hypoxia intervention techniques [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

    The incidence of necessary hypoxia (oxygen saturation below 90%) intervention techniques (performed by the attending anesthesiologist) will be recorded once the patient has been commenced on one lung ventilation. The interventions recorded will be

    1. The need to revert back to two lung ventilation
    2. The need to clamp the operative pulmonary artery
    3. The need to add CPAP to the non ventilated lung despite being in the RM-PEEP arm of the study.
    4. The need to add a RM-PEEP to the ventilated lung despite being in the CPAP arm of the study


Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: 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)
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.
Procedure: 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.

Detailed Description:

Patients requiring one lung ventilation (OLV) for open thoracic surgery will be ventilated intra-operatively using a lung protective ventilation strategy (small tidal volumes {Vts} at 6ml/kg Ideal Body Weight {IBW}). In a randomized, crossover trial Continuous Positive Airway Pressure (CPAP) to the non ventilated lung or a Recruitment Maneuver (RM) followed by the application of Positive End Expiratory Pressure (PEEP) (acronym RM-PEEP) to the ventilated lung will be applied and blood oxygenation (PaO2) measured by arterial blood gas sampling to determine which intervention has the most beneficial effect on PaO2 (CPAP or RM-PEEP).

CPAP will be applied at a pressure of 5cmH2O by a CPAP breathing circuit (designed for the purpose and commonly used in anesthetic practice). The PEEP will be applied at a pressure of 5cmH20 by the operating room (OR) anesthetic machine. The RM will involve a valsalva maneuver, held for 5 seconds at a pressure of 25cmH20, again performed using the OR anesthetic machine.

Null hypothesis: Compared to CPAP, RM-PEEP does not significantly increase PaO2 or reduce the incidence of hypoxia (oxygen blood saturation less than or equal to 90%), when employing a lung protective ventilation strategy.

This study is based on our previous research (citation 12, Badner et al) in which we compared CPAP to PEEP alone (omitting the recruitment maneuver). Here it was noted that CPAP to the non ventilated lung improved oxygenation more than PEEP to the ventilated lung (even though PEEP is an easier modality to provide), when employing a lung protective ventilation strategy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495936

Contacts
Contact: Neal Badner, MD, FRCP (C) 519 685 8500 ext 55115 Neal.Badner@lhsc.on.ca
Contact: George Nicolaou, MD, FRCP (C) 519 685 8500 ext 55115 George.Nicolaou@lhsc.on.ca

Locations
Canada, Ontario
Victoria Hospital Not yet recruiting
London, Ontario, Canada, N6A 5W9
Sub-Investigator: George Nicolaou, MD FRCP (C)         
Sub-Investigator: Rosie Snaith, MB ChB MRCP FRCA         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Neal Badner, MD FRCP (C) Lawson Health Research Institute
  More Information

Publications:

Responsible Party: Neal Badner, Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01495936     History of Changes
Other Study ID Numbers: HSREB 18480
Study First Received: December 16, 2011
Last Updated: December 19, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
One Lung Ventilation (OLV)
Continuous Positive Airway Pressure (CPAP)
Positive End Expiratory Pressure (PEEP)
Lung recruitment maneuver
Hypoxia

ClinicalTrials.gov processed this record on November 24, 2014