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

Acute Hypoxemic Respiratory Failure Clinical Trial

— NPPV  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01151501
• Other study ID #: BeijingCYH-ICU-000
• Status: Withdrawn
• Phase: N/A
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2019
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

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%.

Locations

Country	Name	City	State
China	Beijing Chao Yang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of invasive positive pressure ventilation		two year
Secondary	Incidence of ventilator associated pneumonia		two year
Secondary	Intensive care unit mortality		two years
Secondary	Hospital mortality		two years
Secondary	90-day survival after entry		two years