Obesity Clinical Trial
Official title:
Evaluation of the Risk of Hyperoxia-induced Hypercapnia in Obese Patients in a Cardiac Surgery Postoperative Setting
NCT number | NCT02917668 |
Other study ID # | 21366 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | January 8, 2018 |
Verified date | May 2018 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 8, 2018 |
Est. primary completion date | January 8, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Institut universitaire de cardiologie et de pneumologie de Québec | Québec |
Lead Sponsor | Collaborator |
---|---|
Laval University |
Canada,
Beasley R, Chien J, Douglas J, Eastlake L, Farah C, King G, Moore R, Pilcher J, Richards M, Smith S, Walters H. Thoracic Society of Australia and New Zealand oxygen guidelines for acute oxygen use in adults: 'Swimming between the flags'. Respirology. 2015 Nov;20(8):1182-91. doi: 10.1111/resp.12620. — View Citation
Lellouche F, L'her E. Automated oxygen flow titration to maintain constant oxygenation. Respir Care. 2012 Aug;57(8):1254-62. doi: 10.4187/respcare.01343. Epub 2012 Feb 17. — View Citation
O'Driscoll BR, Howard LS, Davison AG; British Thoracic Society. BTS guideline for emergency oxygen use in adult patients. Thorax. 2008 Oct;63 Suppl 6:vi1-68. doi: 10.1136/thx.2008.102947. Erratum in: Thorax. 2009 Jan;64(1):91. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in PaCO2 | Difference in end-of-period PaCO2 on arterial blood gas | At 30 minutes (first intervention) and at 1h (second intervention) | |
Secondary | Difference in pH | Difference in end-of-period pH on arterial blood gas | At 30 minutes (first intervention) and at 1h (second intervention) | |
Secondary | Difference in PaO2 | Difference in end-of-period PaO2 on arterial blood gas | At 30 minutes (first intervention) and at 1h (second intervention) | |
Secondary | Difference in percentage of time spent in hypoxemia (SpO2 < 88%) | Difference in percentage of time spent in hypoxemia (SpO2 < 88%) between periods | In the first 30 minutes (first intervention) and between 30 min and 1h (second intervention) | |
Secondary | Difference in percentage of time spent in severe hypoxemia (SpO2 < 85 %) | Difference in percentage of time spent in severe hypoxemia (SpO2 < 85 %) between periods | In the first 30 minutes (first intervention) and between 30 min and 1h (second intervention) | |
Secondary | Difference in percentage of time spent in hyperoxemia (SpO2 > 96 %) | Difference in percentage of time spent in hyperoxemia (SpO2 > 96 %) between periods | In the first 30 minutes (first intervention) and between 30 min and 1h (second intervention) | |
Secondary | Difference in respiratory rate (manual and monitor) | Difference in respiratory rate (manual, monitor, FreeO2) between periods for each measuring technique (manual and monitor) | At 0, 10, 20, 30, 40, 50 and 60 minutes | |
Secondary | Difference in mean heart rate | Difference in mean heart rate, recorded continuously by FreeO2, between periods | In the first 30 minutes and between 30 and 60 minutes | |
Secondary | Difference in arterial blood pressure | Difference in arterial blood pressure (systolic, diastolic and mean) between periods | At 0, 10, 20, 30, 40, 50 and 60 minutes | |
Secondary | Difference in pulmonary artery pressure | Difference in pulmonary artery pressure (systolic, diastolic and mean) between periods | At 0, 10, 20, 30, 40, 50 and 60 minutes | |
Secondary | Difference in vasopressor dosage | Difference in vasopressor dosagel at different times between periods | At 0, 10, 20, 30, 40, 50 and 60 minutes | |
Secondary | Difference in body temperature | Difference in body temperature at different times between periods | At 0, 10, 20, 30, 40, 50 and 60 minutes |
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