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

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ClinicalTrials.gov Identifier: NCT02496923
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiac Surgery Device: High flow nasal oxygen therapy (Optiflow™) Device: Standard oxygen therapy (Hudson Type face mask or nasal prongs) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Trial of High-flow Nasal Oxygen (Optiflow™) and Standard Oxygen Therapy in High-risk Patients After Cardiac Surgery
Study Start Date : August 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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 Name: (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 Name: Hudson Type face mask




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. Early postoperative lung function [ Time Frame: Approximately 1 week after surgery ]
    Early postoperative lung function, tested by spirometry

  3. 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.

  4. 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).

  5. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02496923


Locations
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United Kingdom
Department of Cardiothoracic Anaesthesia and Critical Care Medicine, Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Vasileios Zochios, MD Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge, CB23 3RE, United Kingdom
Publications:

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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02496923    
Other Study ID Numbers: P2043
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Keywords provided by Papworth Hospital NHS Foundation Trust:
prophylactic NHFO
risk of developing postoperative pulmonary complications
reduces hospital length of stay