Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure (NPPV)
Recruitment status was Not yet recruiting
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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 |
- Duration of invasive positive pressure ventilation [ Time Frame: two year ] [ Designated as safety issue: Yes ]
- 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 |
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| Contact: Luo Zu Jin, MS | 86-10-13811334549 | xmjg2002@163.com |
| China, Beijing | |
| Beijing Chao Yang Hospital | Not yet recruiting |
| Beijing, Beijing, China, 100020 | |
| Contact: Luo Zu Jin, MS 86-10-13811334549 xmjg2002@163.com | |
| 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 May 22, 2013