Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure (NPPV)
Primary Purpose
Acute Hypoxemic Respiratory Failure
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
noninvasive positive pressure ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure focused on measuring acute hypoxemic respiratory failure, intermittent positive-pressure ventilation, noninvasive positive pressure ventilation, ventilator weaning
Eligibility Criteria
Inclusion Criteria:
- Orotracheal intubation
- Arterial oxygen tension (PaO2)<60mmHg(venturi mask,FiO2=0.5),and arterial carbon dioxide tension(PaCO2)≤45mmHg;
- Meeting standard criteria for weaning readiness
- Suffering failure of spontaneous breathing trial.
Exclusion Criteria:
- Age<18
- Duration of invasive positive pressure ventilation<48h
- Tracheotomy
- Percentage of cuff leak volume in tidal volume<15.5%
- Unable to spontaneously clear secretions from their airway
- Recent oral,nasal,facial or cranial trauma or surgery
- Recent gastric or esophageal surgery
- Active upper gastro-intestinal bleeding
- Severe abdominal distension
- Lack of co-operation
- Chronic respiratory disease such as chronic obstructive pulmonary disease,asthma,interstitial lung disease,etc.
Sites / Locations
- Beijing Chao Yang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
noninvasive positive pressure ventilation
Arm Description
Outcomes
Primary Outcome Measures
Duration of invasive positive pressure ventilation
Secondary Outcome Measures
Incidence of ventilator associated pneumonia
Intensive care unit mortality
Hospital mortality
90-day survival after entry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01151501
Brief Title
Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure
Acronym
NPPV
Official Title
Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
We anticipated that we could not complete this study.
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Acute hypoxaemic respiratory failure (AHRF) refers to pathological states in which arterial blood oxygenation is severely impaired,and which need invasive positive pressure ventilation (IPPV) as respiratory support technique in most cases.However,IPPV carries well-known risks of complications such as ventilator induced lung injury (VILI) or ventilator associated pneumonia (VAP),and the incidence of which is increased as the prolongation of IPPV so as to lead to higher mortality rate. Consequently,early extubation is extraordinarily necessary.
More recently, NPPV has shown to shorten the duration of IPPV,reduce the mortality and morbidity rates in patients with chronic obstructive pulmonary disease (COPD). Despite this evidence, the efficacy of NPPV in patients with AHRF has not been evidenced. However,NPPV has been shown to provide adequate ventilation and oxygenation,and reduce inspiratory muscle effort,neuromuscular drive,and dyspnea scores. Moreover,to some patints,NPPV is similar with IPPV in providing oxygenation.
The duration of weaning is from the first day a patient met standard criteria for weaning readiness to the time of successful extubation (lasting at least 48 h),which represents 40-50% of the total duration of IPPV.As a result,duration of IPPV would be shortened if that of weaning was shortened.
The investigators hypothesized that in mechanical ventilated patients with AHRF who met standard criteria for weaning readiness and suffer failure of spontaneous breathing trial, use of NPPV for early extubation, providing adequate ventilation and oxygenation, would shorten the duration of IPPV as the primary end-point variable, thereby reduce the incidence of complication and mortality rates. Accordingly, the investigators conducted a prospective,randomized clinical trial to assess the efficacy of this strategy compared with the conventional-weaning approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypoxemic Respiratory Failure
Keywords
acute hypoxemic respiratory failure, intermittent positive-pressure ventilation, noninvasive positive pressure ventilation, ventilator weaning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
noninvasive positive pressure ventilation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
noninvasive positive pressure ventilation
Intervention Description
Patients in whom the spontaneous breathing trial fail and in whom exclusion criteria are not present during this period were randomly allocated. Patients who are randomized to NPPV goup will be extubated and non-invasive ventilation (BiPAP Vision, Respironics Inc., Murrysville,Pennsylvania) will be delivered immediately after extubation using spontaneous/timed (S/T) mode. Expiratory positive airways pressure (PEEP) was initially set at 4 cmH2O and gradually increased to 6-8 cmH2O or more;and fraction of inspired oxygen (FiO2) was set to achieve pulse oximeter oxygen saturation (SpO2) >92% in cooperation with PEEP. On condition that tidal volume is no less than 6ml/kg,continuous positive airway pressure (CPAP) is permitted to apply,in which the adjusting procedures of CPAP and FiO2 is similar with PEEP and FiO2 in S/T mode. NPPV is terminated When patients can spontaneously breath oxygen provided by a Venturi device at FiO2≤0.35 for more than 24 hours with SpO2>92%.
Primary Outcome Measure Information:
Title
Duration of invasive positive pressure ventilation
Time Frame
two year
Secondary Outcome Measure Information:
Title
Incidence of ventilator associated pneumonia
Time Frame
two year
Title
Intensive care unit mortality
Time Frame
two years
Title
Hospital mortality
Time Frame
two years
Title
90-day survival after entry
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Orotracheal intubation
Arterial oxygen tension (PaO2)<60mmHg(venturi mask,FiO2=0.5),and arterial carbon dioxide tension(PaCO2)≤45mmHg;
Meeting standard criteria for weaning readiness
Suffering failure of spontaneous breathing trial.
Exclusion Criteria:
Age<18
Duration of invasive positive pressure ventilation<48h
Tracheotomy
Percentage of cuff leak volume in tidal volume<15.5%
Unable to spontaneously clear secretions from their airway
Recent oral,nasal,facial or cranial trauma or surgery
Recent gastric or esophageal surgery
Active upper gastro-intestinal bleeding
Severe abdominal distension
Lack of co-operation
Chronic respiratory disease such as chronic obstructive pulmonary disease,asthma,interstitial lung disease,etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Chen, MD
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhan Q Yuan, MD
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chao Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
12. IPD Sharing Statement
Learn more about this trial
Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure
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