Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure (NPPV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01151501
Recruitment Status : Unknown
Verified June 2010 by Beijing Chao Yang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 28, 2010
Last Update Posted : June 29, 2010
Information provided by:
Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Hypoxemic Respiratory Failure Device: noninvasive positive pressure ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure
Study Start Date : July 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: noninvasive positive pressure ventilation Device: noninvasive positive pressure ventilation
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 Measures :
  1. Duration of invasive positive pressure ventilation [ Time Frame: two year ]

Secondary Outcome Measures :
  1. Incidence of ventilator associated pneumonia [ Time Frame: two year ]
  2. Intensive care unit mortality [ Time Frame: two years ]
  3. Hospital mortality [ Time Frame: two years ]
  4. 90-day survival after entry [ Time Frame: two years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01151501

Contact: Luo Zu Jin, MS 86-10-13811334549

China, Beijing
Beijing Chao Yang Hospital Not yet recruiting
Beijing, Beijing, China, 100020
Contact: Luo Zu Jin, MS    86-10-13811334549   
Sponsors and Collaborators
Beijing Chao Yang Hospital
Study Chair: Wang Chen, MD Beijing Chao Yang Hospital
Study Director: Zhan Q Yuan, MD Beijing Chao Yang Hospital

Responsible Party: Luo Zujin, Beijing Chao Yang Hospital Identifier: NCT01151501     History of Changes
First Posted: June 28, 2010    Key Record Dates
Last Update Posted: June 29, 2010
Last Verified: June 2010

Keywords provided by Beijing Chao Yang Hospital:
acute hypoxemic respiratory failure
intermittent positive-pressure ventilation
noninvasive positive pressure ventilation
ventilator weaning

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases