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

Primary Purpose

Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Nasal high-flow
CPAP
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Failure focused on measuring oxygen therapy, continuous positive airway pressure, extubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ramathibodi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous positive airway pressure

Nasal high-flow

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reintubation rate
Number of participants who required reintubation within 48 hours after extubation

Secondary Outcome Measures

post extubation respiratory failure
Number of participants who required either reintubation or application of Bi-level noninvasive positive airway pressure within 48 hours after extubation

Full Information

First Posted
August 16, 2016
Last Updated
September 27, 2016
Sponsor
Ramathibodi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02918786
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
oxygen therapy, continuous positive airway pressure, extubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous positive airway pressure
Arm Type
Active Comparator
Arm Description
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
Arm Title
Nasal high-flow
Arm Type
Active Comparator
Arm Description
After extubation, patients will receive oxygen therapy through the nasal high-flow (intervention) Intervention: Device: Nasal high-flow
Intervention Type
Device
Intervention Name(s)
Nasal high-flow
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reintubation rate
Description
Number of participants who required reintubation within 48 hours after extubation
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
post extubation respiratory failure
Description
Number of participants who required either reintubation or application of Bi-level noninvasive positive airway pressure within 48 hours after extubation
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
Length of ICU stay
Time Frame
30 days
Title
Patient's discomfort
Description
The investigators will assessed the discomfort of participants by Critical-Care Pain Observation Tool.
Time Frame
48 hours
Title
oxygen desaturations
Description
The participants will be monitored and recorded oxygen saturation with the pulse oximeter at 15 minutes, 2 hours, 24 hours and 48 hours after extubation
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pongdhep Theerawit, MD
Phone
662011619
Email
pongdhep.the@mahidol.ac.th
Facility Information:
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pongdhep Theerawit, MD
Phone
662011619
Email
pongdhep.the@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Yuda Sutherasan, MD
Phone
662011619
Email
sutherasan_yuda@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yuda Sutherasan, MD
First Name & Middle Initial & Last Name & Degree
Pongdhep Theerawit, MD
First Name & Middle Initial & Last Name & Degree
Nattawat Nudphobsuk, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25003980
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.
Results Reference
background
PubMed Identifier
16276167
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.
Results Reference
background
PubMed Identifier
19380311
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.
Results Reference
background
PubMed Identifier
10806150
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.
Results Reference
background
PubMed Identifier
19616722
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.
Results Reference
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The Efficacy of the Whisperflow CPAP System Versus Nasal High Flow in Patients at High Risk for Postextubation Failure

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