Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure (NPPV)
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 25, 2010 | ||||||||
| Last Updated Date | June 28, 2010 | ||||||||
| Start Date ICMJE | July 2010 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Duration of invasive positive pressure ventilation [ Time Frame: two year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01151501 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure | ||||||||
| Official Title ICMJE | Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Acute Hypoxemic Respiratory Failure | ||||||||
| Intervention ICMJE | 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%. |
||||||||
| Study Arm (s) | Experimental: noninvasive positive pressure ventilation
Intervention: Device: noninvasive positive pressure ventilation |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 52 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01151501 | ||||||||
| Other Study ID Numbers ICMJE | NCT20100616 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Luo Zujin, Beijing Chao Yang Hospital | ||||||||
| Study Sponsor ICMJE | Beijing Chao Yang Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Beijing Chao Yang Hospital | ||||||||
| Verification Date | June 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||