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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Beijing Chao Yang Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT01151501
First received: June 25, 2010
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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 Intervention
Acute Hypoxemic Respiratory Failure
Device: noninvasive positive pressure ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Beijing Chao Yang Hospital:

Primary Outcome Measures:
  • Duration of invasive positive pressure ventilation [ Time Frame: two year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of ventilator associated pneumonia [ Time Frame: two year ] [ Designated as safety issue: No ]
  • Intensive care unit mortality [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: two years ] [ Designated as safety issue: No ]
  • 90-day survival after entry [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: July 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151501

Contacts
Contact: Luo Zu Jin, MS 86-10-13811334549 xmjg2002@163.com

Locations
China, Beijing
Beijing Chao Yang Hospital Not yet recruiting
Beijing, Beijing, China, 100020
Contact: Luo Zu Jin, MS    86-10-13811334549    xmjg2002@163.com   
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
Study Chair: Wang Chen, MD Beijing Chao Yang Hospital
Study Director: Zhan Q Yuan, MD Beijing Chao Yang Hospital
  More Information

No publications provided

Responsible Party: Luo Zujin, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT01151501     History of Changes
Other Study ID Numbers: NCT20100616
Study First Received: June 25, 2010
Last Updated: June 28, 2010
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on October 19, 2014