Oxygenation Targets in Cardiac Surgery Patients - a Before-and-after Study

NCT04133740 | Unknown Phase 4

• 1 other identifier: AAUH-ANAESTH-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

During surgery high concentrations of supplementary oxygen are routinely administrated. However, there is increasing evidence of potential harm with liberal oxygen therapy. The hypothesis of the present study is that oxygen therapy adjusted to a normal arterial oxygen target is feasible and will attenuate the side effects of supplementary oxygen therapy. The study design is a before-and-after study in which 25 patients will follow the standard regime with high concentrations of oxygen therapy and 25 patients will be treated with oxygen to achieve a normal value of arterial oxygenation.

Conditions

Hyperoxia; Cardiac Surgery; Cardiopulmonary Bypass; Acute Lung Injury; Oxygen Toxicity

Keywords

A before-and-after study; Oxygenation targeting

Outcome Measures

Primary Outcomes (1)

• P/F ratio

  Ratio of fraction of inspired oxygen (FiO2) and partial pressure of arterial oxygen (PaO2)

  Third postoperative day

Study Arms (2)

Standard regime

ACTIVE COMPARATOR

Supplementary oxygen is given according to the standard regime with a fraction of inspired oxygen (FiO2) of at least 0.60 during mechanical ventilation and 3 liter/minute or more after weaning from the ventilator in the intensive care unit (ICU).

Drug: Oxygen

Oxygenation targeting

ACTIVE COMPARATOR

Supplementary oxygen is given to achieve a partial pressure of arterial oxygen (PaO2) within the normal range defined as 10-12 kPa (75-120 mmHg) during surgery and in the ICU.

Drug: Oxygen

Interventions

Oxygen DRUG

Liberal versus conservative oxygen therapy.

Also known as: Oxygen therapy

Oxygenation targeting; Standard regime

Eligibility Criteria

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

You may qualify if:

• Scheduled for elective cardiac surgery either coronary artery bypass grafting and/or valve replacement performed with use of cardiopulmonary bypass

You may not qualify if:

• Left ventricular ejection fraction below 30 percent

Sponsors & Collaborators

• Aalborg University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Dept. of Intensive Care, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Hyperoxia; Acute Lung Injury

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Bodil S Rasmussen, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant

Model Details: A before-and-after study in which the first half to the planned patients are following the standard regime for oxygen therapy with a fixed amount and the other half of the patients receive oxygen therapy to achieve normal levels of partial pressure of arterial oxygen.

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 21, 2019
• Study Start: October 1, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 31, 2020
• Last Updated: October 28, 2019

Record last verified: 2019-10

Locations

DK (1)