PALIVE1: Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury

Sponsor

St. Justine's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00521625

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury Acute Respiratory Distress Syndrome

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.

Study Design

Study Type:

Observational

Time Perspective:

Prospective

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 Start Date :

Jun 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Onset of hypoxemia was acute
Bilateral infiltrates on chest X-Ray
No clinical evidence of congestive heart failure
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

Contacts and Locations

Locations

	Site	City	State	Country
1	Children's Hospital Los Angeles	Los Angeles	California	United States
2	Children's Hospital at Oakland	Oakland	California	United States
3	The Children's Hospital	Denver	Colorado	United States
4	Connecticut Children's Medical Center	Hartford	Connecticut	United States
5	Miami Children's Hospital	Miami	Florida	United States
6	Children's Memorial Hospital	Chicago	Illinois	United States
7	Riley Hospital for Children	Indianapolis	Indiana	United States
8	Kentucky Children's Hospital	Lexington	Kentucky	United States
9	UMAss Memorial Medical Center	Worchester	Massachusetts	United States
10	Children's Mercy Hospital	Kansas City	Missouri	United States
11	Children's Hospital	Omaha	Nebraska	United States
12	Nebraska Medical Center	Omaha	Nebraska	United States
13	Darmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States
14	New York Presbyterian Hospital	New York	New York	United States
15	Duke University Medical Center	Durham	North Carolina	United States
16	Penn State Children's Hospital	Hershey	Pennsylvania	United States
17	The Children's hospital Philadelphia	Philadelphia	Pennsylvania	United States
18	Children's Hospital of Austin	Austin	Texas	United States
19	Texas Childrens Hospital	Houston	Texas	United States
20	Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States
21	Akademisches Lehrkrankenhaus	Feldkirch		Austria
22	Medical University of Vienna	Vienna		Austria
23	Paola Childrens Hospital	Antwerp		Belgium
24	Cliniques universitaires Saint-Luc	Brussels		Belgium
25	Hôpital SteJustine	Montreal	Quebec	Canada
26	Montreal Children' Hospital	Montreal	Quebec	Canada
27	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada
28	Stollery Children's Hospital	Edmonton		Canada
29	McMaster Children's Hospital	Hamilton		Canada
30	Children's Hospital of Western Ontario	London		Canada
31	Centre Hospitalier Universitaire de Quebec	Quebec		Canada
32	BC Children's Hospital	Vancouver		Canada
33	CHU Lille	Lille		France
34	CHU Nantes	Nantes		France
35	Hôpital Robert-Debré	Paris		France
36	Necker	Paris		France
37	CHU Pontchaillou	Rennes		France
38	University Clinic Frankfurt	Frankfurt		Germany
39	Universitätsklinikum Mannheim	Mannheim		Germany
40	Kinderzentrum im Klinikum Nürnberg	Nurnberg		Germany
41	Children's Hospital StAugustin	St Augustin		Germany
42	University Children's Hospital	Tuebringen		Germany
43	Ospedali riuniti di Bergamo	Bergamo		Italy
44	Padua University Hospital	Padova		Italy
45	Azienda Ospedaliera di Verona	Verona		Italy
46	The Wilhelmina Children's Hospital	Utrecht		Netherlands
47	Hospital Sant Joan de Déu-Hospital Clinic	Barcelona		Spain
48	Cruces Hospital	Bilbao		Spain
49	General University Hospital Gregorio Marañón	Madrid		Spain
50	Hospital Universitario Central de Asturias	Oveido		Spain
51	Hospital universitario de Salamanca	Salamanca		Spain
52	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostella		Spain
53	Hospital Infantil La Fe	Valencia		Spain
54	The Queen Silvia Children's Hospital	Goteborg		Sweden
55	Astrid Lindgren Children's Hospital	Stockholm		Sweden
56	Children's Hospital	Geneva		Switzerland
57	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland
58	Bristol Children's Hospital	Bristol		United Kingdom