Cardiac SurgeryNCT02496923
High Flow Nasal Oxygen Therapy (Optiflow™) in High-risk Cardiac Surgical Patients
A study testing High flow nasal oxygen therapy (Optiflow™) and Standard oxygen therapy (Hudson Type face mask or nasal prongs) in people with Cardiac Surgery, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- High flow nasal oxygen therapy (Optiflow™) and Standard oxygen therapy (Hudson Type face mask or nasal prongs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Cardiothoracic Anaesthesia and Critical Care Medicine, Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB23 3RE
About this study
Official title: 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.
Read more
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.
- Conditions
- Cardiac Surgery
- Being tested
- High flow nasal oxygen therapy (Optiflow™), Standard oxygen therapy (Hudson Type face mask or nasal prongs)
- Keywords
- prophylactic NHFO, risk of developing postoperative pulmonary complications, reduces hospital length of stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal oxygen therapy (Optiflow™)Device
Also called (Optiflow™)
Standard oxygen therapy (Hudson Type face mask or nasal prongs)Device
Also called Hudson Type face mask
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal oxygen therapy (Optiflow™) | Experimental | 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. Receives: Device: High flow nasal oxygen therapy (Optiflow™) |
| Standard oxygen therapy (Hudson face mask or nasal prongs) | Active comparator | 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). Receives: Device: Standard oxygen therapy (Hudson Type face mask or nasal prongs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay (days)
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).
Measured: 10 days (plus or minus 3 days) after surgery
Secondary outcomes (5)
Early postoperative recovery
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
Measured: 1 month
Early postoperative lung function
Early postoperative lung function, tested by spirometry
Measured: Approximately 1 week after surgery
Intensive care unit readmission rate
Determine if prophylactic NHFO therapy in high-risk cardiac surgical patients, is associated with reduced intensive care unit readmission rate.
Measured: First 24 hours after surgery
Intensive Care Unit length of stay (hours)
Determine if prophylactic NHFO therapy in high-risk cardiac surgical patients, is associated with shorter ICU length of stay (days).
Measured: 30 hours (plus or minus 24 hours)
Escalation of respiratory support
First 24 hours after surgery
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vasileios Zochios, MD, Principal investigator, Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge, CB23 3RE, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496923
- Sponsor's protocol ID
- P2043
- Status last verified
- Nov 2017
- First submitted
- 22 Jun 2015
- Last updated
- 2 Dec 2017
- Results posted
- No
Publications
Pasquina P, Merlani P, Granier JM, Ricou B. Continuous positive airway pressure versus noninvasive pressure support ventilation to treat atelectasis after cardiac surgery. Anesth Analg. 2004 Oct;99(4):1001-1008. doi: 10.1213/01.ANE.0000130621.11024.97.
PubMed 15385340Wynne R, Botti M. Postoperative pulmonary dysfunction in adults after cardiac surgery with cardiopulmonary bypass: clinical significance and implications for practice. Am J Crit Care. 2004 Sep;13(5):384-93.
PubMed 15470854Taggart DP, el-Fiky M, Carter R, Bowman A, Wheatley DJ. Respiratory dysfunction after uncomplicated cardiopulmonary bypass. Ann Thorac Surg. 1993 Nov;56(5):1123-8. doi: 10.1016/0003-4975(95)90029-2.
PubMed 8239811Weissman C. Pulmonary complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):185-211. doi: 10.1177/108925320400800303.
PubMed 15375480Adabag AS, Wassif HS, Rice K, Mithani S, Johnson D, Bonawitz-Conlin J, Ward HB, McFalls EO, Kuskowski MA, Kelly RF. Preoperative pulmonary function and mortality after cardiac surgery. Am Heart J. 2010 Apr;159(4):691-7. doi: 10.1016/j.ahj.2009.12.039.
PubMed 20362731Manganas H, Lacasse Y, Bourgeois S, Perron J, Dagenais F, Maltais F. Postoperative outcome after coronary artery bypass grafting in chronic obstructive pulmonary disease. Can Respir J. 2007 Jan-Feb;14(1):19-24. doi: 10.1155/2007/378963.
PubMed 17315054Leavitt BJ, Ross CS, Spence B, Surgenor SD, Olmstead EM, Clough RA, Charlesworth DC, Kramer RS, O'Connor GT; Northern New England Cardiovascular Disease Study Group. Long-term survival of patients with chronic obstructive pulmonary disease undergoing coronary artery bypass surgery. Circulation. 2006 Jul 4;114(1 Suppl):I430-4. doi: 10.1161/CIRCULATIONAHA.105.000943.
PubMed 16820614Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
PubMed 15791115Lumb AB, Greenhill SJ, Simpson MP, Stewart J. Lung recruitment and positive airway pressure before extubation does not improve oxygenation in the post-anaesthesia care unit: a randomized clinical trial. Br J Anaesth. 2010 May;104(5):643-7. doi: 10.1093/bja/aeq080. Epub 2010 Mar 30.
PubMed 20354010Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18.
PubMed 19017864Kindgen-Milles D, Muller E, Buhl R, Bohner H, Ritter D, Sandmann W, Tarnow J. Nasal-continuous positive airway pressure reduces pulmonary morbidity and length of hospital stay following thoracoabdominal aortic surgery. Chest. 2005 Aug;128(2):821-8. doi: 10.1378/chest.128.2.821.
PubMed 16100174Lenique F, Habis M, Lofaso F, Dubois-Rande JL, Harf A, Brochard L. Ventilatory and hemodynamic effects of continuous positive airway pressure in left heart failure. Am J Respir Crit Care Med. 1997 Feb;155(2):500-5. doi: 10.1164/ajrccm.155.2.9032185.
PubMed 9032185Westerlind A, Nilsson F, Ricksten SE. The use of continuous positive airway pressure by face mask and thoracic epidural analgesia after lung transplantation. Gothenburg Lung Transplant Group. J Cardiothorac Vasc Anesth. 1999 Jun;13(3):249-52. doi: 10.1016/s1053-0770(99)90258-6.
PubMed 10392672Parke RL, Eccleston ML, McGuinness SP. The effects of flow on airway pressure during nasal high-flow oxygen therapy. Respir Care. 2011 Aug;56(8):1151-5. doi: 10.4187/respcare.01106. Epub 2011 Apr 15.
PubMed 21496369Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20.
PubMed 19846404
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of High-flow Nasal Oxygen (Optiflow™) and Standard Oxygen Therapy in High-risk Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02496923
- Acronym / sponsor ID
- P2043
- Conditions
- Cardiac Surgery
- Keywords
- prophylactic NHFO, risk of developing postoperative pulmonary complications, reduces hospital length of stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Aug 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal oxygen therapy (Optiflow™) | Experimental | Device: 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. |
| Standard oxygen therapy (Hudson face mask or nasal prongs) | Active comparator | Device: Standard oxygen therapy (Hudson Type 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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal oxygen therapy (Optiflow™)Also: (Optiflow™) | Device | High flow nasal oxygen therapy (Optiflow™) |
| Standard oxygen therapy (Hudson Type face mask or nasal prongs)Also: Hudson Type face mask | Device | Standard oxygen therapy (Hudson face mask or nasal prongs) |
Primary outcome
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).
5 secondary outcomes
Early postoperative recovery
Time frame: 1 month
Early postoperative lung function
Time frame: Approximately 1 week after surgery
Intensive care unit readmission rate
Time frame: First 24 hours after surgery
Intensive Care Unit length of stay (hours)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Background: PubMed 15385340Pasquina P, Merlani P, Granier JM, Ricou B. Continuous positive airway pressure versus noninvasive pressure support ventilation to treat atelectasis after cardiac surgery. Anesth Analg. 2004 Oct;99(4):1001-1008. doi: 10.1213/01.ANE.0000130621.11024.97.
- Background: PubMed 15470854Wynne R, Botti M. Postoperative pulmonary dysfunction in adults after cardiac surgery with cardiopulmonary bypass: clinical significance and implications for practice. Am J Crit Care. 2004 Sep;13(5):384-93.
- Background: PubMed 8239811Taggart DP, el-Fiky M, Carter R, Bowman A, Wheatley DJ. Respiratory dysfunction after uncomplicated cardiopulmonary bypass. Ann Thorac Surg. 1993 Nov;56(5):1123-8. doi: 10.1016/0003-4975(95)90029-2.
- Background: PubMed 15375480Weissman C. Pulmonary complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):185-211. doi: 10.1177/108925320400800303.
- Background: PubMed 20362731Adabag AS, Wassif HS, Rice K, Mithani S, Johnson D, Bonawitz-Conlin J, Ward HB, McFalls EO, Kuskowski MA, Kelly RF. Preoperative pulmonary function and mortality after cardiac surgery. Am Heart J. 2010 Apr;159(4):691-7. doi: 10.1016/j.ahj.2009.12.039.
- Background: PubMed 17315054Manganas H, Lacasse Y, Bourgeois S, Perron J, Dagenais F, Maltais F. Postoperative outcome after coronary artery bypass grafting in chronic obstructive pulmonary disease. Can Respir J. 2007 Jan-Feb;14(1):19-24. doi: 10.1155/2007/378963.
- Background: PubMed 16820614Leavitt BJ, Ross CS, Spence B, Surgenor SD, Olmstead EM, Clough RA, Charlesworth DC, Kramer RS, O'Connor GT; Northern New England Cardiovascular Disease Study Group. Long-term survival of patients with chronic obstructive pulmonary disease undergoing coronary artery bypass surgery. Circulation. 2006 Jul 4;114(1 Suppl):I430-4. doi: 10.1161/CIRCULATIONAHA.105.000943.
- Background: PubMed 15791115Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
- Background: PubMed 20354010Lumb AB, Greenhill SJ, Simpson MP, Stewart J. Lung recruitment and positive airway pressure before extubation does not improve oxygenation in the post-anaesthesia care unit: a randomized clinical trial. Br J Anaesth. 2010 May;104(5):643-7. doi: 10.1093/bja/aeq080. Epub 2010 Mar 30.
- Background: PubMed 19017864Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18.
- Background: PubMed 16100174Kindgen-Milles D, Muller E, Buhl R, Bohner H, Ritter D, Sandmann W, Tarnow J. Nasal-continuous positive airway pressure reduces pulmonary morbidity and length of hospital stay following thoracoabdominal aortic surgery. Chest. 2005 Aug;128(2):821-8. doi: 10.1378/chest.128.2.821.
- Background: PubMed 9032185Lenique F, Habis M, Lofaso F, Dubois-Rande JL, Harf A, Brochard L. Ventilatory and hemodynamic effects of continuous positive airway pressure in left heart failure. Am J Respir Crit Care Med. 1997 Feb;155(2):500-5. doi: 10.1164/ajrccm.155.2.9032185.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasileios Zochios, MD principal investigator
Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge, CB23 3RE, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal oxygen therapy (Optiflow™) and Standard oxygen therapy (Hudson Type face mask or nasal prongs) in people with Cardiac Surgery, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (days) (time frame: 10 days (plus or minus 3 days) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02496923, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.