- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00549809
Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
June 27, 2008 updated by: UPECLIN HC FM Botucatu Unesp
Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent mandatory ventilation associated with pressure support (SIMV/PS) related to duration of mechanical ventilation/weaning and length of stay in PICU (LS).
Design: randomized clinical trial.
Setting: Pediatric intensive care unit at a university-affiliated hospital.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent mandatory ventilation associated with pressure support (SIMV/PS) related to duration of mechanical ventilation/weaning and length of stay in PICU (LS).
Design: randomized clinical trial.
Setting: Pediatric intensive care unit at a university-affiliated hospital.
Patients: children between 28 days and 4 years old, admitted between 10/2002 and 06/2004, and receiving mechanical ventilation (MV) for more than 48 hours.
Patients were randomly assigned into two groups: IMV (IMVG; n=35) and SIMV/PS (SIMVG; n=35).
Children with acute respiratory distress syndrome and tracheostomy were excluded.
Ventilation and oxygenation data were recorded at admission and beginning of weaning.
Results: Groups were not statistically different for age, gender, MV indications, PRISM score, COMFORT scale, sedatives, and ventilation and oxygenation parameters.
Median of MV duration was 5 days for both groups (p>0.05).
Also, there were no statistical differences for duration of weaning [IMVG: 1 day (1 - 6) vs. SIMVG: 1 day (1 - 6); p>0.05] and LS [IMVG: 8 days (2 - 22) vs. SIMVG: 6 days (3 - 20); p>0.05].
Conclusion: There was no statistically significant difference between IMV and SIMV/PS in these children related to MV and weaning duration, and PICU length of stay.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sao Paulo
-
Botucatu, Sao Paulo, Brazil, 18.618-000
- Jose Roberto Fioretto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children aged between 28 days and four years, who were consecutively admitted to the PICU and required MV for more than 48h were included.
Exclusion Criteria:
- Children who had chronic respiratory failure, tracheostomy, those transferred from the hospital, or died were excluded as were patients with acute respiratory distress syndrome (ARDS).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: IMV, SIMV
|
Patients divided to receive two different modes of mechanical ventilation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
duration of mechanical ventilation/weaning and length of stay in PICU
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jose R Fioretto, MD, PhD, UNESP - Botucatu Medical School
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
October 25, 2007
First Submitted That Met QC Criteria
October 25, 2007
First Posted (Estimate)
October 26, 2007
Study Record Updates
Last Update Posted (Estimate)
July 2, 2008
Last Update Submitted That Met QC Criteria
June 27, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- upeclin/HC/FMB-Unesp-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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