The Effect of Two Airway Interventions, During One Lung Ventilation, on Blood Oxygen Content
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| First Received Date ICMJE | December 16, 2011 | ||||||||
| Last Updated Date | December 19, 2011 | ||||||||
| Start Date ICMJE | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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]) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01495936 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effect of Two Airway Interventions, During One Lung Ventilation, on Blood Oxygen Content | ||||||||
| Official Title ICMJE | 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. | ||||||||
| 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:
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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Thoracic, Diseases | ||||||||
| Intervention ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01495936 | ||||||||
| Other Study ID Numbers ICMJE | HSREB 18480 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Neal Badner, Lawson Health Research Institute | ||||||||
| Study Sponsor ICMJE | Lawson Health Research Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Lawson Health Research Institute | ||||||||
| Verification Date | December 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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