The Efficacy of the Whisperflow CPAP System Versus Nasal High Flow in Patients at High Risk for Postextubation Failure

NCT02918786 | Unknown

• 1 other identifier: ID 12-58-11
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

oxygen therapy; continuous positive airway pressure; extubation

Outcome Measures

Primary Outcomes (1)

• Reintubation rate

  Number of participants who required reintubation within 48 hours after extubation

  48 hours

Secondary Outcomes (1)

• post extubation respiratory failure

  48 hours

Other Outcomes (3)

• Length of ICU stay

  30 days

• Patient's discomfort

  48 hours

• oxygen desaturations

  48 hours

Study Arms (2)

Continuous positive airway pressure

ACTIVE COMPARATOR

After extubation, patients will receive continuous positive airway pressure (CPAP) delivered by the variable generator WhisperFlow System (control) Intervention:Device : CPAP of 5 cmH2O delivered by the variable generator WhisperFlow System for 48 hours

Device: CPAP

Nasal high-flow

ACTIVE COMPARATOR

After extubation, patients will receive oxygen therapy through the nasal high-flow (intervention) Intervention: Device: Nasal high-flow

Device: Nasal high-flow

Interventions

Nasal high-flow DEVICE

After extubation, the patients will receive oxygen delivered through the nasal high-flow system (Optiflow™). The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients. Gas flow will be set until maximal level of 60 LPM.

Nasal high-flow

CPAP DEVICE

After extubation, patients will receive CPAP at 5 cmH2O delivered by the variable generator WhisperFlow System. The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients.

Continuous positive airway pressure

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Ramathibodi Hospital

Bangkok, 10400, Thailand

RECRUITING

Related Publications (5)

• 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.

  PMID: 25003980 BACKGROUND

• 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.

  PMID: 16276167 BACKGROUND

• 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.

  PMID: 19380311 BACKGROUND

• 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.

  PMID: 10806150 BACKGROUND

• 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.

  PMID: 19616722 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Pongdhep Theerawit, MD

CONTACT

662011619; pongdhep.the@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: September 29, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

TH (1)