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NCT00521625 Clinical Trial

Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury

Acute Respiratory Distress Syndrome Clinical Trial

— PALIVE1  

Official title:
Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury - Phase 1 PALIVE 1 (for Pediatric Acute Lung Injury Mechanical VEntilation Strategies)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00521625
Other study ID # PALIVE1
Secondary ID
Status Completed
Phase N/A
First received August 24, 2007
Last updated May 21, 2008
Start date June 2007
Est. completion date November 2007

Study information
Verified date May 2008
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in children with an acute lung injury (ALI). The objective of the study is to describe mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily clinical practice is heterogenous among pediatric intensivists as few pediatric data exists on optimal mechanical ventilation strategies in this group of patients. Furthermore, different strategies may affect patient outcome.

Description:

INTRODUCTION Few pediatric data exists on the ventilation mode and parameters that would provide the greatest benefit with the least risk to an individual pediatric patient with Acute Lung Injury (ALI). Current expert opinion is that it is reasonable to follow adult recommendations and to adapt clinical management in children according to adult data. In the absence of consensus and established guidelines for mechanical ventilation in children with ALI, we believe that the daily clinical practice in pediatric intensive care units is subject to great variations according to the experience, comfort and knowledge of the attending intensivist.

METHODS Objective: Describe invasive and non-invasive mechanical ventilation in pediatric cases of ALI.

Hypothesis: There is an important variability in the observed practice pattern of mechanical ventilation in pediatric cases of ALI.

Design: An international cross-sectional epidemiologic study in Pediatric Intensive Care Units on the observed practice pattern of invasive and non-invasive mechanical ventilation in children with ALI.

Setting: Pediatric Intensive Care Units in Canada, United States, Europe.

Patients: Patients less than 18 years old on invasive or non-invasive mechanical ventilation with a diagnosis of ALI on the day of the study.

Measurements: Demographic data on included patients; their underlying chronic disease and acute disease leading to non-invasive mechanical ventilation or intubation and mechanical ventilation; data on mechanical ventilation mode and parameters, vital signs, lab results, radiographic findings, treatments, complications of mechanical ventilation will be recorded every 6 hours for 24 hours. A web based case report form will be developed.

Sample size: We plan to conduct the study on isolated days at least one month apart until we reach 200 patients with ALI, to include at least 10 patients on high frequency ventilation. We estimate that with 5 days of study in 70 centers we should reach this number.

FUTURE CONSIDERATIONS We believe this study will provide important data on the actual mechanical ventilation strategies in pediatric patients with ALI. The next step will be to conduct a prospective international study on mechanical ventilation strategies and to follow patients prospectively during the whole course of their mechanical ventilation.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Child on invasive mechanical ventilation administered through an endotracheal tube or a tracheostomy tube, or on non-invasive mechanical ventilation administered through a nasal or facial mask or a nasal canula or helmet at 9 a.m. on the day of the study.

- Presence of ALI as estimated by the attending physician:

1. Onset of hypoxemia was acute

2. Bilateral infiltrates on chest X-Ray

3. No clinical evidence of congestive heart failure

4. Sustained hypoxemia defined as:

PaO2(mmHg)/FiO2 ratio = 300 or PaO2(kPa)/FiO2 = 40

If no arterial canula or no arterial blood gas:

SpO2/FiO2 = 320 with SpO2 < 0.98 (10)

Exclusion Criteria:

- Post conceptional age < 42 weeks

- Age > 18 years

- Non-corrected cyanotic congenital heart disease or evidence of extra-pulmonary right to left shunt

- Withdrawal/withholding of care

- Brain death

- No consent, if required

- Patient on ECMO

- Already included in this study

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Lung Injury
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn

Locations
Country Name City State
Austria Akademisches Lehrkrankenhaus Feldkirch
Austria Medical University of Vienna Vienna
Belgium Paola Childrens Hospital Antwerp
Belgium Cliniques universitaires Saint-Luc Brussels
Canada Stollery Children's Hospital Edmonton
Canada McMaster Children's Hospital Hamilton
Canada Children's Hospital of Western Ontario London
Canada Hôpital SteJustine Montreal Quebec
Canada Montreal Children' Hospital Montreal Quebec
Canada Centre Hospitalier Universitaire de Quebec Quebec
Canada Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec
Canada BC Children's Hospital Vancouver
France CHU Lille Lille
France CHU Nantes Nantes
France Hôpital Robert-Debré Paris
France Necker Paris
France CHU Pontchaillou Rennes
Germany University Clinic Frankfurt Frankfurt
Germany Universitätsklinikum Mannheim Mannheim
Germany Kinderzentrum im Klinikum Nürnberg Nurnberg
Germany Children's Hospital StAugustin St Augustin
Germany University Children's Hospital Tuebringen
Italy Ospedali riuniti di Bergamo Bergamo
Italy Padua University Hospital Padova
Italy Azienda Ospedaliera di Verona Verona
Netherlands The Wilhelmina Children's Hospital Utrecht
Spain Hospital Sant Joan de Déu-Hospital Clinic Barcelona
Spain Cruces Hospital Bilbao
Spain General University Hospital Gregorio Marañón Madrid
Spain Hospital Universitario Central de Asturias Oveido
Spain Hospital universitario de Salamanca Salamanca
Spain Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostella
Spain Hospital Infantil La Fe Valencia
Sweden The Queen Silvia Children's Hospital Goteborg
Sweden Astrid Lindgren Children's Hospital Stockholm
Switzerland Children's Hospital Geneva
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne
United Kingdom Bristol Children's Hospital Bristol
United States Children's Hospital of Austin Austin Texas
United States Children's Memorial Hospital Chicago Illinois
United States The Children's Hospital Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States Connecticut Children's Medical Center Hartford Connecticut
United States Penn State Children's Hospital Hershey Pennsylvania
United States Texas Childrens Hospital Houston Texas
United States Riley Hospital for Children Indianapolis Indiana
United States Children's Mercy Hospital Kansas City Missouri
United States Darmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Kentucky Children's Hospital Lexington Kentucky
United States Children's Hospital Los Angeles Los Angeles California
United States Miami Children's Hospital Miami Florida
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States New York Presbyterian Hospital New York New York
United States Children's Hospital at Oakland Oakland California
United States Children's Hospital Omaha Nebraska
United States Nebraska Medical Center Omaha Nebraska
United States The Children's hospital Philadelphia Philadelphia Pennsylvania
United States UMAss Memorial Medical Center Worchester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
St. Justine's Hospital

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

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