Clinical trial NCT02918786: The Efficacy of the Whisperflow CPAP System Versus Nasal High Flow in Patients at High Risk for Postextubation Failure
Official title: The Efficacy of the Whisperflow CPAP System Versus High Flow Nasal Cannula Oxygen Therapy in Patients at High Risk for Postextubation Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Keywords: oxygen therapy
continuous positive airway pressure
extubation
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effect of continuous positive airway pressure (CPAP) delivered by the variable generator WhisperFlow System with high flow nasal cannula oxygen therapy in mechanically ventilated patient who are at risk for postextubation failure.

Detailed description: Postextubation respiratory failure is not an uncommon condition after discontinuation of mechanical ventilation. Subsequently reintubation and mechanical ventilation for postextubation respiratory failure may lead to increasing of hospital morbidity and mortality and and prolonging intensive care and hospital stay. Several studies have demonstrated the efficacy of non-invasive ventilation to prevent the postextubation failure in patients with high risk for extubation failure.

The variable generator whisper flow system ((Philips Respironics, Murrysville, PA, USA) is the one of widely used continuous positive airway pressure(CPAP) device in UK. This device employs an oxygen-driven venturi to entrain air and generates high fresh gas flow up to 140 liter per minute. The oxygen/air mixture enters the breathing circuit and exits through a threshold resistor namely CPAP valve. Whisperflow is able to provide the flow into the breathing system via oronasal mask which exceeds the peak inspiratory flow rate of the patient and may improve work of breathing as well as gas exchange. In daily clinical practice, the investigators apply this device with humidifier in patients with weaning difficulty and patients who are at risk for postextubation failure.

High-flow nasal oxygen therapy(HFNO) is a device which heated and humidified oxygen is distributed to the nose at high flow rates. With the high flow rate (up to 60 Liter per minute), it generates low level of positive airway pressure. Physiological benefits of HFNO comprises decreasing of the dead space, work of breathing and the low level of positive airway pressure associated with better lung recruitment. Furthermore, the fraction of inspired oxygen can be adjusted and measured by changing the fraction of oxygen in the driving gas.

In the present randomized, controlled trial, the investigators will compare two devices for oxygen therapy, with low levels of continuous positive airway pressure, nasal high-flow oxygen therapy and CPAP of 5 cmH2O delivered by the variable generator WhisperFlow System with oronasal mask , in critically ill patients who are at risk for postextubation failure. The investigators hypothesize that nasal high-flow is superior to CPAP the in terms of reintubation rate.

Eligibility criteria: Inclusion Criteria:

* Mechanical ventilation \> 48 hours and
* high risk for extubation failure namely , congestive heart failure, ineffective cough and excessive tracheobronchial secretions, more than one failure of a weaning trial, more than one co-morbid condition, patients who had hypercapnia, and upper airway obstruction without immediately required intubation

Exclusion Criteria:

* age\<18 years
* pregnancy
* tracheostomy
* uncontrolled cardiac ischemia or arrhythmias
* unstable hemodynamic status
* documented swallowing problem
* documented cervical spine injury
* Facial anatomical abnormalities interfering with the mask fit
* agitated or uncooperative state
* lack of informed consent

Primary outcomes:
measure: Reintubation rate
timeFrame: 48 hours
Secondary outcomes:
measure: post extubation respiratory failure
timeFrame: 48 hours
Other outcomes:
measure: Length of ICU stay
timeFrame: 30 days
measure: Patient's discomfort
timeFrame: 48 hours
measure: oxygen desaturations
timeFrame: 48 hours
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
References:
citation: Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
citation: Nava S, Gregoretti C, Fanfulla F, Squadrone E, Grassi M, Carlucci A, Beltrame F, Navalesi P. Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients. Crit Care Med. 2005 Nov;33(11):2465-70. doi: 10.1097/01.ccm.0000186416.44752.72.
citation: Glover GW, Fletcher SJ. Assessing the performance of the Whisperflow continuous positive airway pressure generator: a bench study. Br J Anaesth. 2009 Jun;102(6):875-81. doi: 10.1093/bja/aep077. Epub 2009 Apr 19.
citation: Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.
citation: Nava S, Hill N. Non-invasive ventilation in acute respiratory failure. Lancet. 2009 Jul 18;374(9685):250-9. doi: 10.1016/S0140-6736(09)60496-7.