Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial

This study has been completed.
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00549809
First received: October 25, 2007
Last updated: June 27, 2008
Last verified: June 2008

October 25, 2007
June 27, 2008
October 2005
February 2007   (final data collection date for primary outcome measure)
duration of mechanical ventilation/weaning and length of stay in PICU [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
duration of mechanical ventilation/weaning and length of stay in PICU [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00549809 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial

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.

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.

Interventional
Phase 3
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Respiratory Failure
Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV
Patients divided to receive two different modes of mechanical ventilation.
Other Names:
  • IMV (intermittent mandatory ventilation)
  • SIMV (synchronous intermittent mandatory ventilation)
Active Comparator: IMV, SIMV
Intervention: Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV
de 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. Epub 2008 Nov 6. English, Portuguese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
June 2007
February 2007   (final data collection date for primary outcome measure)

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).
Both
up to 4 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00549809
upeclin/HC/FMB-Unesp-04
No
José Roberto Fioretto, UNESP - Botucatu Medical School
UPECLIN HC FM Botucatu Unesp
Not Provided
Principal Investigator: Jose R Fioretto, MD, PhD UNESP - Botucatu Medical School
UPECLIN HC FM Botucatu Unesp
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP