Acute Lung InjuryPALIVE1NCT00521625
Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by St. Justine's Hospital at 58 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome
- How many people
- Not given
- Where
- 58 sitesin 12 countries
- Study dates
- Jun 2007to Nov 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
58 sites in 12 countries.
58 sites in 12 countries
United States20 sites
Children's Hospital of Austin
Austin, Texas
Children's Memorial Hospital
Chicago, Illinois
The Children's Hospital
Denver, Colorado
Duke University Medical Center
Durham, North Carolina
Connecticut Children's Medical Center
Hartford, Connecticut
Penn State Children's Hospital
Hershey, Pennsylvania
Texas Childrens Hospital
Houston, Texas
Riley Hospital for Children
Indianapolis, Indiana
Children's Mercy Hospital
Kansas City, Missouri
Darmouth-Hitchcock Medical Center
Lebanon, New Hampshire
Kentucky Children's Hospital
Lexington, Kentucky
Children's Hospital Los Angeles
Los Angeles, California
Miami Children's Hospital
Miami, Florida
Children's Hospital of Wisconsin
Milwaukee, Wisconsin
New York Presbyterian Hospital
New York, New York
Children's Hospital at Oakland
Oakland, California
Children's Hospital
Omaha, Nebraska
Nebraska Medical Center
Omaha, Nebraska
The Children's hospital Philadelphia
Philadelphia, Pennsylvania
UMAss Memorial Medical Center
Worchester, Massachusetts
Canada8 sites
Stollery Children's Hospital
Edmonton
McMaster Children's Hospital
Hamilton
Children's Hospital of Western Ontario
London
Hôpital SteJustine
Montreal, Quebec
Montreal Children' Hospital
Montreal, Quebec
Centre Hospitalier Universitaire de Quebec
Québec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
BC Children's Hospital
Vancouver
Spain7 sites
Hospital Sant Joan de Déu-Hospital Clinic
Barcelona
Cruces Hospital
Bilbao
General University Hospital Gregorio Marañón
Madrid
Hospital Universitario Central de Asturias
Oveido
Hospital universitario de Salamanca
Salamanca
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Hospital Infantil La Fe
Valencia
France5 sites
CHU Lille
Lille
CHU Nantes
Nantes
Hôpital Robert-Debré
Paris
Necker
Paris
CHU Pontchaillou
Rennes
Germany5 sites
University Clinic Frankfurt
Frankfurt
Universitätsklinikum Mannheim
Mannheim
Kinderzentrum im Klinikum Nürnberg
Nuremberg
Children's Hospital StAugustin
Sankt Augustin
University Children's Hospital
Tuebringen
Italy3 sites
Ospedali riuniti di Bergamo
Bergamo
Padua University Hospital
Padova
Azienda Ospedaliera di Verona
Verona
Austria2 sites
Akademisches Lehrkrankenhaus
Feldkirch
Medical University of Vienna
Vienna
Belgium2 sites
Paola Childrens Hospital
Antwerp
Cliniques universitaires Saint-Luc
Brussels
Sweden2 sites
The Queen Silvia Children's Hospital
Gothenburg
Astrid Lindgren Children's Hospital
Stockholm
Switzerland2 sites
Children's Hospital
Geneva
Centre Hospitalier Universitaire Vaudois
Lausanne
About this study
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)
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.
Read the 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.
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startJun 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Jouvet, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521625
- Sponsor's protocol ID
- PALIVE1
- Acronym
- PALIVE1
- Status last verified
- May 2008
- First submitted
- 24 Aug 2007
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00521625
- Acronym / sponsor ID
- PALIVE1 / PALIVE1
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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:
- PaO2(mmHg)/FiO2 ratio ≤ 300 or PaO2(kPa)/FiO2 ≤ 40
- SpO2/FiO2 ≤ 320 with SpO2 < 0.98 (10)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
- Web site for the study's data collectionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Jouvet, MD principal investigator
St. Justine's Hospital
58 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by St. Justine's Hospital at 58 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada, Spain, France, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.