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

NCT02917668 | Completed

• 1 other identifier: 21366
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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%.

Conditions

Obesity; Hyperoxia; Hypercapnia

Keywords

Obesity; Hyperoxia; Hypercapnia; Postoperative complications; Cardiac surgical procedures

Outcome Measures

Primary Outcomes (1)

• Difference in PaCO2

  Difference in end-of-period PaCO2 on arterial blood gas

  At 30 minutes (first intervention) and at 1h (second intervention)

Secondary Outcomes (11)

• Difference in pH

  At 30 minutes (first intervention) and at 1h (second intervention)

• Difference in PaO2

  At 30 minutes (first intervention) and at 1h (second intervention)

• Difference in percentage of time spent in hypoxemia (SpO2 < 88%)

  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 %)

  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 %)

  In the first 30 minutes (first intervention) and between 30 min and 1h (second intervention)

Study Arms (2)

Group A

ACTIVE COMPARATOR

15 patients who will receive usual care for 30 minutes and then switch to FreeO2 for another 30 minutes

Other: FreeO2; Other: Usual care

Group B

ACTIVE COMPARATOR

15 patients who will be oxygenated by FreeO2 for 30 minutes and then switch to usual care for another 30 minutes

Other: FreeO2; Other: Usual care

Interventions

FreeO2 OTHER

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 %

Group A; Group B

Usual care OTHER

Oxygen delivery manually titrated by the nursing staff for a SpO2 target of \> or = 95 %

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V4G5, Canada

Location

Related Publications (4)

• 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.

  PMID: 26486092 BACKGROUND

• 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. No abstract available.

  PMID: 18838559 BACKGROUND

• 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.

  PMID: 22348812 BACKGROUND

• Denault MH, Ruel C, Simon M, Bouchard PA, Simard S, Lellouche F. Evaluation of hyperoxia-induced hypercapnia in obese patients after cardiac surgery: a randomized crossover comparison of conservative and liberal oxygen administration. Can J Anaesth. 2020 Feb;67(2):194-202. doi: 10.1007/s12630-019-01500-x. Epub 2019 Oct 24.

  PMID: 31650500 DERIVED

MeSH Terms

Conditions

Obesity; Hyperoxia; Hypercapnia; Postoperative Complications

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Pathologic Processes

Study Officials

• François Lellouche, MD, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: September 28, 2016
• Study Start: September 1, 2016
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)