High Flow Nasal Oxygen Therapy (Optiflow™) in High-risk Cardiac Surgical Patients

November 29, 2017 updated by: Papworth Hospital NHS Foundation Trust

A Randomised Controlled Trial of High-flow Nasal Oxygen (Optiflow™) and Standard Oxygen Therapy in High-risk Patients After Cardiac Surgery

Background:

High risk patients with lung disease who undergo cardiac surgery are at significant risk of postoperative complications leading to prolonged hospital stay. One method of reducing the risk of lung complications is to treat patients with non-invasive ventilation or continuous positive airways pressure postoperatively. However, this often requires admission to a high dependency unit or intensive care, and is uncomfortable because of the need for a tight fitting mask, as well as being labour intensive and costly. Nasal high flow oxygen (Optiflow™) is a new alternative as it provides warmed humidified oxygen at high flow, and also has been shown to assist breathing and improve recovery. It is comfortable during use and indeed may be more comfortable than standard (dry) oxygen via a facemask (Hudson type) or nasal prongs. It may be administered on a normal ward, however its routine use in high risk patients with lung conditions such as asthma, chronic obstructive pulmonary disease, recent chest infections and heavy smokers has not been tested before.

Aims/Objectives:

The primary aim of this clinical trial is to determine if prophylactic nasal high flow oxygen (Optiflow™) therapy in cardiac surgical patients at high-risk of developing post-operative pulmonary complications is associated with shorter hospital length of stay.

Methods:

High risk adult patients who are scheduled to undergo cardiac surgery will be recruited with full ethical approval and informed consent. Before surgery, each patient will perform a 6- minute walking test under the supervision of a physiotherapist. This simple tests measures how far patients can walk in 6 minutes. Additionally, patients will undergo spirometry testing which is used to assess how well the lungs work by measuring how much air the patient inhales and exhales and how quickly they exhale. Patients will thereafter undergo surgery under general anaesthesia as they would normally. After the operation they will be looked after following our recovery protocols, incorporating pain relief, regular physiotherapy, early mobilisation and eating and drinking, and removal of chest drains and tubes as soon as possible.

On arrival in the critical care area after their surgery, patients will be randomly assigned to receive supplemental oxygen via a soft facemask (Hudson Type) (standard group), or via high-flow nasal cannulae(Optiflow™) (intervention group). Patients will be administered oxygen for at least 24 hours after surgery.

Patients who develop breathing difficulty will receive treatment based on their clinical need. On the fifth or sixth postoperative day they will repeat the walking test and spirometry. The investigators will use a short questionnaire to determine if there is any difference in how patients feel they recovered before they leave hospital and how quickly they returned to normal activities after discharge, and also to evaluate how they tolerated either the facemask (Hudson Type) or high flow nasal cannulae (Optiflow™).

The investigators have used data from previous studies to calculate that a total of 74 patients will be needed to take part, in order to evaluate whether high flow nasal oxygen (Optiflow™) leads to reduced length of hospital stay after high risk cardiac surgery compared with usual care oxygen therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
        • Department of Cardiothoracic Anaesthesia and Critical Care Medicine, Papworth Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients are eligible for inclusion if:

  • they are aged over 18 years
  • are undergoing elective cardiac surgery (coronary artery bypass grafting, valve surgery or both)
  • they have one or more patient-related risk factor for post-operative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks, body mass index≥35 kg/m2 current (last 6 weeks) heavy smokers (> 10 packyears)).
  • they are capable of performing a 6MWT - The 6MWT is a clinical exercise test, and is popular in clinical practice because it aids clinical decision making, and because of the belief that it provides a better estimate of functional capacity than resting cardiorespiratory measurements (24). The 6MWT is the most popular clinical exercise test, which is used for postoperative evaluation after lung surgery and has also been validated in cardiac surgery

Exclusion Criteria:

  • Contraindication to high flow nasal oxygen such as nasal septal defect.
  • Not met extubation criteria by 10am the day after surgery (Day 1).
  • Need for CPAP pre-operatively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High flow nasal oxygen therapy (Optiflow™)
In patients randomised to receive high flow nasal oxygen therapy (HFNO) the gas flow through the HFNO will be calculated for each patient, based on their body characteristics, and comfort level. The standard starting flow rate will be 30 L/min, and this will be adjusted up or down between a range of 20-50 L/min with the aim of achieving both patient comfort and a respiratory rate of less than 16 breaths per minute.
Device: High flow nasal oxygen therapy (Optiflow™)
Other Names:
  • (Optiflow™)
Active Comparator: Standard oxygen therapy (Hudson face mask or nasal prongs)
Patients randomised to receive standard oxygen therapy will be fitted with a soft face mask or nasal prongs, and the oxygen flow titrated to provide pulse oxygen saturation of at least 95% (93% for those at risk of hypercapnic respiratory failure such as confirmed COPD patients and morbidly obese patients). The standard oxygen therapy group will have their oxygen gas flow reduced to the minimum level which provides saturations of at least 95% (93% for those at risk of hypercapnic respiratory failure such as patients with confirmed COPD and morbidly obese patients).
Device: Standard oxygen therapy (Hudson Type face mask or nasal prongs)
Other Names:
  • Hudson Type face mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay (days)
Time Frame: 10 days (plus or minus 3 days) after surgery
To determine if prophylactic nasal high flow oxygen (NHFO) therapy in cardiac surgical patients at high-risk of developing post-operative pulmonary complications, is associated with shorter hospital length of stay (days).
10 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early postoperative recovery
Time Frame: 1 month
Early postoperative recovery, as determined by performance on a 6 minute walking test, compared with patients who receive standard (soft face mask or nasal prongs) oxygen therapy
1 month
Early postoperative lung function
Time Frame: Approximately 1 week after surgery
Early postoperative lung function, tested by spirometry
Approximately 1 week after surgery
Intensive care unit readmission rate
Time Frame: First 24 hours after surgery
Determine if prophylactic NHFO therapy in high-risk cardiac surgical patients, is associated with reduced intensive care unit readmission rate.
First 24 hours after surgery
Intensive Care Unit length of stay (hours)
Time Frame: 30 hours (plus or minus 24 hours)
Determine if prophylactic NHFO therapy in high-risk cardiac surgical patients, is associated with shorter ICU length of stay (days).
30 hours (plus or minus 24 hours)
Escalation of respiratory support
Time Frame: Determine if prophylactic NHFO in high-risk cardiac surgical patients, is associated with reduced requirement for escalation of respiratory support (invasive or non-invasive respiratory support) First 24 hours after surgery
First 24 hours after surgery
Determine if prophylactic NHFO in high-risk cardiac surgical patients, is associated with reduced requirement for escalation of respiratory support (invasive or non-invasive respiratory support) First 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papworth Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Vasileios Zochios, MD, Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge, CB23 3RE, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P2043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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