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Evaluation of the Risk of Hyperoxia-induced Hypercapnia in Obese Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT02917668
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
François Lellouche, Laval University

Brief Summary:
This study aims to evaluate the risk of hyperoxia-induced hypercapnia in post-op obese cardiac surgery patients. It will compare two oxygenation modes in terms of their effect on the arterial partial pressure of carbon dioxide (PaCO2) : manual titration of oxygen delivery for a peripheral oxygen saturation (SpO2) target of > or = 95 % versus automatic titration by a closed-loop system for a SpO2 target of 90%. 15 post-op obese cardiac surgery patients will be recruited and each will receive both interventions (cross-over design). The main outcome will be the PaCO2, which will be compared after each study period. The research hypothesis is that the usual SpO2 target of > or = 95 % is associated with a greater PaCO2 compared with a lesser SpO2 target of 90%.

Condition or disease Intervention/treatment Phase
Obesity Hyperoxia Hypercapnia Other: FreeO2 Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Risk of Hyperoxia-induced Hypercapnia in Obese Patients in a Cardiac Surgery Postoperative Setting
Study Start Date : September 2016
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : January 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: Group A
15 patients who will receive usual care for 30 minutes and then switch to FreeO2 for another 30 minutes
Other: FreeO2
Oxygen delivery automatically titrated by a closed-loop system that adjusts the oxygen flow based on the patient's real-time SpO2 and a programed SpO2 target of 90 %

Other: Usual care
Oxygen delivery manually titrated by the nursing staff for a SpO2 target of > or = 95 %

Active Comparator: Group B
15 patients who will be oxygenated by FreeO2 for 30 minutes and then switch to usual care for another 30 minutes
Other: FreeO2
Oxygen delivery automatically titrated by a closed-loop system that adjusts the oxygen flow based on the patient's real-time SpO2 and a programed SpO2 target of 90 %

Other: Usual care
Oxygen delivery manually titrated by the nursing staff for a SpO2 target of > or = 95 %




Primary Outcome Measures :
  1. Difference in PaCO2 [ Time Frame: At 30 minutes (first intervention) and at 1h (second intervention) ]
    Difference in end-of-period PaCO2 on arterial blood gas


Secondary Outcome Measures :
  1. Difference in pH [ Time Frame: At 30 minutes (first intervention) and at 1h (second intervention) ]
    Difference in end-of-period pH on arterial blood gas

  2. Difference in PaO2 [ Time Frame: At 30 minutes (first intervention) and at 1h (second intervention) ]
    Difference in end-of-period PaO2 on arterial blood gas

  3. Difference in percentage of time spent in hypoxemia (SpO2 < 88%) [ Time Frame: In the first 30 minutes (first intervention) and between 30 min and 1h (second intervention) ]
    Difference in percentage of time spent in hypoxemia (SpO2 < 88%) between periods

  4. Difference in percentage of time spent in severe hypoxemia (SpO2 < 85 %) [ Time Frame: In the first 30 minutes (first intervention) and between 30 min and 1h (second intervention) ]
    Difference in percentage of time spent in severe hypoxemia (SpO2 < 85 %) between periods

  5. Difference in percentage of time spent in hyperoxemia (SpO2 > 96 %) [ Time Frame: In the first 30 minutes (first intervention) and between 30 min and 1h (second intervention) ]
    Difference in percentage of time spent in hyperoxemia (SpO2 > 96 %) between periods

  6. Difference in respiratory rate (manual and monitor) [ Time Frame: At 0, 10, 20, 30, 40, 50 and 60 minutes ]
    Difference in respiratory rate (manual, monitor, FreeO2) between periods for each measuring technique (manual and monitor)

  7. Difference in mean heart rate [ Time Frame: In the first 30 minutes and between 30 and 60 minutes ]
    Difference in mean heart rate, recorded continuously by FreeO2, between periods

  8. Difference in arterial blood pressure [ Time Frame: At 0, 10, 20, 30, 40, 50 and 60 minutes ]
    Difference in arterial blood pressure (systolic, diastolic and mean) between periods

  9. Difference in pulmonary artery pressure [ Time Frame: At 0, 10, 20, 30, 40, 50 and 60 minutes ]
    Difference in pulmonary artery pressure (systolic, diastolic and mean) between periods

  10. Difference in vasopressor dosage [ Time Frame: At 0, 10, 20, 30, 40, 50 and 60 minutes ]
    Difference in vasopressor dosagel at different times between periods

  11. Difference in body temperature [ Time Frame: At 0, 10, 20, 30, 40, 50 and 60 minutes ]
    Difference in body temperature at different times between periods



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 30 kg/m2
  • SpO2 > or = 95 % before extubation
  • Procedure : coronary artery bypass

Exclusion Criteria:

  • Comorbidities : chronic obstructive pulmonary disease, cystic fibrosis, restrictive syndrome not associated with obesity (pulmonary fibrosis, neuromuscular junction disease, etc.)
  • Obstructive sleep apnea requiring a positive-pressure mask in the posteoperative period
  • FreeO2 device unavailable
  • Inclusion in another study that does not permit dual inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917668


Locations
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Canada
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Canada, G1V4G5
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: François Lellouche, MD, PhD Laval University
  Study Documents (Full-Text)

Documents provided by François Lellouche, Laval University:
Study Protocol  [PDF] July 13, 2017

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: François Lellouche, MD, PhD, Laval University
ClinicalTrials.gov Identifier: NCT02917668    
Other Study ID Numbers: 21366
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators would like to publish our results in scientific magazine and/or present them in a Conference.
Keywords provided by François Lellouche, Laval University:
Obesity
Hyperoxia
Hypercapnia
Postoperative complications
Cardiac surgical procedures
Additional relevant MeSH terms:
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Hypercapnia
Hyperoxia
Signs and Symptoms, Respiratory