Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Intermittent mandatory ventilation (IMV) and synchronous IMV
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring mechanical ventilation; respiratory failure
Eligibility Criteria
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).
Sites / Locations
- Jose Roberto Fioretto
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
IMV, SIMV
Arm Description
Outcomes
Primary Outcome Measures
duration of mechanical ventilation/weaning and length of stay in PICU
Secondary Outcome Measures
Full Information
NCT ID
NCT00549809
First Posted
October 25, 2007
Last Updated
June 27, 2008
Sponsor
UPECLIN HC FM Botucatu Unesp
1. Study Identification
Unique Protocol Identification Number
NCT00549809
Brief Title
Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
Official Title
Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
mechanical ventilation; respiratory failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMV, SIMV
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Intermittent mandatory ventilation (IMV) and synchronous IMV
Other Intervention Name(s)
IMV (intermittent mandatory ventilation), SIMV (synchronous intermittent mandatory ventilation)
Intervention Description
Patients divided to receive two different modes of mechanical ventilation.
Primary Outcome Measure Information:
Title
duration of mechanical ventilation/weaning and length of stay in PICU
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose R Fioretto, MD, PhD
Organizational Affiliation
UNESP - Botucatu Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jose Roberto Fioretto
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18.618-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
18989547
Citation
Moraes MA, Bonatto RC, Carpi MF, Ricchetti SM, Padovani CR, Fioretto JR. Comparison between intermittent mandatory ventilation and synchronized intermittent mandatory ventilation with pressure support in children. J Pediatr (Rio J). 2009 Jan-Feb;85(1):15-20. doi: 10.2223/JPED.1849. Epub 2008 Nov 6. English, Portuguese.
Results Reference
derived
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Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
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