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

NCT02496923 | Completed

• 1 other identifier: P2043
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

prophylactic NHFO; risk of developing postoperative pulmonary complications; reduces hospital length of stay

Outcome Measures

Primary Outcomes (1)

• 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).

  10 days (plus or minus 3 days) after surgery

Secondary Outcomes (5)

• Early postoperative recovery

  1 month

• Early postoperative lung function

  Approximately 1 week after surgery

• Intensive care unit readmission rate

  First 24 hours after surgery

• Intensive Care Unit length of stay (hours)

  30 hours (plus or minus 24 hours)

• Escalation of respiratory support

  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

Study Arms (2)

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.

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).

Device: Standard oxygen therapy (Hudson Type face mask or nasal prongs)

Interventions

High flow nasal oxygen therapy (Optiflow™) DEVICE

Also known as: (Optiflow™)

High flow nasal oxygen therapy (Optiflow™)

Standard oxygen therapy (Hudson Type face mask or nasal prongs) DEVICE

Also known as: Hudson Type face mask

Standard oxygen therapy (Hudson face mask or nasal prongs)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Department of Cardiothoracic Anaesthesia and Critical Care Medicine, Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Related Publications (24)

• 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.

  PMID: 15385340 BACKGROUND

• Wynne 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.

  PMID: 15470854 BACKGROUND

• Taggart 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.

  PMID: 8239811 BACKGROUND

• Weissman C. Pulmonary complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):185-211. doi: 10.1177/108925320400800303.

  PMID: 15375480 BACKGROUND

• Adabag 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.

  PMID: 20362731 BACKGROUND

• Manganas 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.

  PMID: 17315054 BACKGROUND

• Leavitt 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.

  PMID: 16820614 BACKGROUND

• Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.

  PMID: 15791115 BACKGROUND

• Lumb 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.

  PMID: 20354010 BACKGROUND

• Zarbock 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.

  PMID: 19017864 BACKGROUND

• Kindgen-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.

  PMID: 16100174 BACKGROUND

• Lenique 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.

  PMID: 9032185 BACKGROUND

• Westerlind 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.

  PMID: 10392672 BACKGROUND

• Parke 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.

  PMID: 21496369 BACKGROUND

• Parke 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.

  PMID: 19846404 BACKGROUND

• Frizzola M, Miller TL, Rodriguez ME, Zhu Y, Rojas J, Hesek A, Stump A, Shaffer TH, Dysart K. High-flow nasal cannula: impact on oxygenation and ventilation in an acute lung injury model. Pediatr Pulmonol. 2011 Jan;46(1):67-74. doi: 10.1002/ppul.21326. Epub 2010 Nov 23.

  PMID: 21171186 BACKGROUND

• Cuquemelle E, Lellouche F. Assessment of humidification performance: still no easy method! Respir Care. 2013 Sep;58(9):1559-61. doi: 10.4187/respcare.02761. No abstract available.

  PMID: 23981591 BACKGROUND

• Manley BJ, Owen LS, Doyle LW, Andersen CC, Cartwright DW, Pritchard MA, Donath SM, Davis PG. High-flow nasal cannulae in very preterm infants after extubation. N Engl J Med. 2013 Oct 10;369(15):1425-33. doi: 10.1056/NEJMoa1300071.

  PMID: 24106935 BACKGROUND

• Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.

  PMID: 19467849 BACKGROUND

• Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.

  PMID: 21908497 BACKGROUND

• Corley A, Bull T, Spooner AJ, Barnett AG, Fraser JF. Direct extubation onto high-flow nasal cannulae post-cardiac surgery versus standard treatment in patients with a BMI >/=30: a randomised controlled trial. Intensive Care Med. 2015 May;41(5):887-94. doi: 10.1007/s00134-015-3765-6. Epub 2015 Apr 8.

  PMID: 25851385 BACKGROUND

• Weisman IM, Zeballos RJ. Clinical exercise testing. Clin Chest Med. 2001 Dec;22(4):679-701, viii. doi: 10.1016/s0272-5231(05)70060-5.

  PMID: 11787659 BACKGROUND

• Fiorina C, Vizzardi E, Lorusso R, Maggio M, De Cicco G, Nodari S, Faggiano P, Dei Cas L. The 6-min walking test early after cardiac surgery. Reference values and the effects of rehabilitation programme. Eur J Cardiothorac Surg. 2007 Nov;32(5):724-9. doi: 10.1016/j.ejcts.2007.08.013. Epub 2007 Sep 18.

  PMID: 17881241 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

Study Officials

• Vasileios Zochios, MD

  Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge, CB23 3RE, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 14, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

GB (1)