Post Intensive Care SyndromeNCT05227989
Outcome of Children Post Mechanical Ventilation
An observational study of Post Intensive Care Syndrome, run by St. Justine's Hospital at 4 sites in Canada.
Trial summary
Mechanical ventilation is a life-saving therapy widely used in PICU, but not without adverse effects. The mid-term outcome of mechanically ventilated children who survive critical illness is still poorly defined, in terms of respiratory status, functionality, and quality of life. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Post Intensive Care Syndrome
- How many people
- 100 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Dec 2022to 1 Sep 2024
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children admitted to a PICU requiring mechanical ventilation for at least 48 hours.
Who may be able to join
- Patients < 18 years of age;
- Admission to a PICU at the Centre Hospitalier Universitaire Sainte-Justine (CHUSJ), Montreal Children's Hospital (MCH), Centre Hospitalier Universitaire de Québec - Université Laval (CHUL) or Centre Hospitalier Universitaire de Sherbrooke (CHUS);
- Patients with invasive mechanical ventilation for ≥48 hours.
Who cannot join
- Patients admitted for congenital heart surgery
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Laurence Ducharme-Crevier, 514-345-4931 ext. 4118, lducharmecrevier@gmail.com
- Recruiting
Hôpital de Montréal pour enfants (MCH)
Montreal, Quebec
Patricia Fontela, MD PhD
- Not yet recruiting
Centre Hospitalier Universitaire de Québec - Université Laval (CHUL)
Québec
Conal Francoeur, MD MSc
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec
Jean-Sébastien Tremblay-Roy, MD
About this study
Official title: Functional and Respiratory Outcomes of Mechanically Ventilated Children in Pediatric Intensive Care, a Prospective Cohort Study
Mechanical ventilation is a life-saving therapy widely used in PICU, but not without adverse effects. The mid-term outcome of mechanically ventilated children who survive critical illness is still poorly defined, in terms of respiratory status, functionality, and quality of life. This lack of knowledge can lead to delays in management and thus hinder the recovery of children.
The aim of this study is to determine the impact on the functional and respiratory outcome of pediatric patients after a stay a PICU of the province of Quebec.
Read the detailed description
This is a prospective longitudinal cohort study of pediatric patients requiring mechanical ventilation for at least 48 hours, in all 4 PICUs in the province of Quebec (Canada).
In follow-up PICU clinics, children and family outcomes will be evaluated 2, 6 and 12 months post PICU discharge.Children and their families will be enrolled locally from each PICU, their baseline data will be collected by local research staff and their post-discharge outcomes will be followed centrally from the Centre Hospitalier Universitaire Sainte-Justine.
The specific aims are to determine the functional, respiratory and neurocognitive function of PICU survivors and Health related Quality of life. Psychosocial status of the child and parents will also be determined.
The primary goal is to describe the impact of a critical illness and mechanical ventilation on PICU survivors and their families in order to improve the health and well-being of PICU survivors and their families, and ultimately to improve the care of children after a PICU stay.
- Conditions
- Post Intensive Care Syndrome
- Medical subject headings
- postintensive care syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status
Functional Status Scale (FSS) Final scores range from 6 to 30 Higher scores mean a worse outcome.
Measured: 12 months
Secondary outcomes (5)
Respiratory status
6 minute walk test Result expressed in meters Higher score means better function
Measured: 12 months
Health related Quality of life
PedsQL™ 4.0 Generic Core or Infant Scales (self report or report parent) Final scores range from 0 to 100 Higher scores mean a better outcome
Measured: 12 months
Psychosocial status of the child
Child PTSD Symptom Scale for DSM-5 (CPSS-5) (children 1year+) The total severity score ranges from 0 to 80 Higher scores mean a worse outcome.
Measured: 12 months
Psychosocial status of the parents
Hospital Anxiety \& Depression Scale (HADS) (parents) Each category (Anxiety and Depression) range from 0 to 21) Higher scores mean a worse outcome.
Measured: 12 months
Neurocognition
Test according to age of patient:
Bayley Scales of Infant Development III (1-30months) Wechsler Preschool and Primary Scale of Intelligence IV (WPPSI) (30months-7year) Wechsler Intelligence Scale for Children V (WISC)(7-16year) Wechsler Adult Intelligence Scale IV (WAIS)(16year+) These tests provide standardized norms, percentiles and age equivalent percentiles. The mean score is 100 ± SD15.
Higher score mean better functioning
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Dec 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care SyndromeStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Laval University
- Responsible party
- Principal investigator, Laurence Ducharme-Crevier, St. Justine's Hospital
- Investigators
- Laurence Ducharme-Crevier, MD MSc, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227989
- Sponsor's protocol ID
- MP-21-2022-3571
- Status last verified
- Feb 2023
- First submitted
- 13 Jan 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Respiratory Outcomes of Mechanically Ventilated Children in Pediatric Intensive Care, a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05227989
- Acronym / sponsor ID
- MP-21-2022-3571
- Conditions
- Post Intensive Care Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Laval University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 8 Feb 2022 (actual)
- 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.
Mechanical ventilation is a life-saving therapy widely used in PICU, but not without adverse effects. The mid-term outcome of mechanically ventilated children who survive critical illness is still poorly defined, in terms of respiratory status, functionality, and quality of life. This lack of knowledge can lead to delays in management and thus hinder the recovery of children.
The aim of this study is to determine the impact on the functional and respiratory outcome of pediatric patients after a stay a PICU of the province of Quebec.
Detailed description
This is a prospective longitudinal cohort study of pediatric patients requiring mechanical ventilation for at least 48 hours, in all 4 PICUs in the province of Quebec (Canada).
In follow-up PICU clinics, children and family outcomes will be evaluated 2, 6 and 12 months post PICU discharge.Children and their families will be enrolled locally from each PICU, their baseline data will be collected by local research staff and their post-discharge outcomes will be followed centrally from the Centre Hospitalier Universitaire Sainte-Justine.
The specific aims are to determine the functional, respiratory and neurocognitive function of PICU survivors and Health related Quality of life. Psychosocial status of the child and parents will also be determined.
The primary goal is to describe the impact of a critical illness and mechanical ventilation on PICU survivors and their families in order to improve the health and well-being of PICU survivors and their families, and ultimately to improve the care of children after a PICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children admitted to a PICU requiring mechanical ventilation for at least 48 hours.
Key inclusion criteria (3 listed)
- Patients < 18 years of age;
- Admission to a PICU at the Centre Hospitalier Universitaire Sainte-Justine (CHUSJ), Montreal Children's Hospital (MCH), Centre Hospitalier Universitaire de Québec - Université Laval (CHUL) or Centre Hospitalier Universitaire de Sherbrooke (CHUS);
- Patients with invasive mechanical ventilation for ≥48 hours.
Key exclusion criteria (1 listed)
- Patients admitted for congenital heart surgery
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
Functional status
Time frame: 12 months
Functional Status Scale (FSS) Final scores range from 6 to 30 Higher scores mean a worse outcome.
5 secondary outcomes
Respiratory status
Time frame: 12 months
Health related Quality of life
Time frame: 12 months
Psychosocial status of the child
Time frame: 12 months
Psychosocial status of the parents
Time frame: 12 months
Neurocognition
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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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.
Laurence Ducharme-Crevier, MD MSc principal investigator
St. Justine's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Intensive Care Syndrome, run by St. Justine's Hospital at 4 sites in Canada.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence Ducharme-Crevier, MD MSc (514-345-4931 ext. 4118, lducharmecrevier@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status (time frame: 12 months). It is what the study was designed to measure, not a finding.
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 16 Feb 2023.