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Noninvasive Positive Pressure Ventilation for ALI/ARDS:a Multicentre Randomized Controlled Trial

3. april 2007 opdateret af: Beijing Chao Yang Hospital

with appropriate inspired oxygen concentrations, NPPV would prevent intubation and hence avert the poor outcome associated with the need of invasive ventilation in patients with ALI/ARDS.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Enhed: ikke-invasiv overtryksventilation

Detaljeret beskrivelse

Noninvasive positive-pressure ventilation (NPPV) is increasingly being used in the care of patients suffering acute respiratory failure. High-level evidence supports the use of NPPV to treat exacerbation of chronic obstructive pulmonary disease (COPD). More recently, NIV has shown to reduce the need for intubation in selected groups of patients with severe cardiogenic pulmonary edema, immunosuppression, and respiratory failure after lung resection. In their subgroup analysis of the five randomized control trials, however, patients with acute lung injury (ALI) or ARDS still couldn't avoid intubation and death even treated with NPPV. Till now, there has been no randomized controlled study of NPPV in patients with ALI or ARDS. We hypothesized that in patients with ALI/ARDS, early use of NPPV, providing appropriate inspired oxygen concentrations, would prevent intubation as the primary end-point variable, hence avert the poor outcome associated with the need of invasive ventilation. Accordingly, we conducted a prospective, randomized controlled trial to assess the efficacy of NPPV compared with a standard regime consisting of high-concentration oxygen therapy.

Undersøgelsestype

Interventionel

Tilmelding

200

Fase

Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Kina
- - Beijing, Kina, 100020
    - Rekruttering
    - Beijing chaoyang hospital-affiliate of capital medical university
    - Kontakt:
      
      Zhan Q Yuan, MD
      
      Telefonnummer: 86-10-65060167
      
      E-mail: zhanqy0915@163.com
    - Kontakt:
      
      Sun Bin, MS
      
      Telefonnummer: 86-10-85231893
      
      E-mail: ards@vip.163.com
    - Ledende efterforsker:
      
      Wang Chen, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Meet the ALI/ARDS criteria

Exclusion Criteria:

Age > 85
pH < 7.35 or PaCO2 >50mmHg
Glasgow Coma Scale (GCS)<11
Airway or facial deformity
Pneumothorax or pneumomediastinum
Unable to spontaneously clear secretions from their airway
Respiratory arrest
Shock or hemodynamic instability (systolic blood pressure <90 mmHg associated with decreased urinary output (<20 mL.h-1) despite fluid repletion and use of vasoactive agents) of other causes
Severe ventricular arrhythmia or active myocardial ischemia
Severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score>1)
End-stage patients who are expected to survive less than six months
Severe abdominal distension
Refuse to receive NPPV
Unable to cooperate with the application of NPPV

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Enkelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
The intubation rate who meet the intubation criteria predefined

Sekundære resultatmål

Resultatmål
Mortality in the ICU and hospital

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Chao Yang Hospital

Efterforskere

Studiestol: Wang Chen, MD, Beijing Chao Yang Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2006

Studieafslutning (Forventet)

1. december 2007

Datoer for studieregistrering

Først indsendt

23. juni 2006

Først indsendt, der opfyldte QC-kriterier