Clinical trial NCT00521625: Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Acute Respiratory Distress Syndrome
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2007-08-28
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief 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.

Detailed 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.

Eligibility criteria: 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

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