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Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
This study has been completed.
First Received: October 25, 2007   Last Updated: June 27, 2008   History of Changes
Sponsored by: UPECLIN HC FM Botucatu Unesp
Information provided by: UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT00549809
  Purpose

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.


Condition Intervention Phase
Respiratory Failure
Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Single Blind (Subject), Parallel Assignment
Official Title: Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • duration of mechanical ventilation/weaning and length of stay in PICU [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: October 2005
Study Completion Date: June 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IMV, SIMV: Active Comparator Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV
Patients divided to receive two different modes of mechanical ventilation.

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.

  Eligibility

Ages Eligible for Study:   up to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549809

Locations
Brazil, Sao Paulo
Jose Roberto Fioretto
Botucatu, Sao Paulo, Brazil, 18.618-000
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Principal Investigator: Jose R Fioretto, MD, PhD UNESP - Botucatu Medical School
  More Information

No publications provided by UPECLIN HC FM Botucatu Unesp

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: UNESP - Botucatu Medical School ( José Roberto Fioretto )
Study ID Numbers: upeclin/HC/FMB-Unesp-04
Study First Received: October 25, 2007
Last Updated: June 27, 2008
ClinicalTrials.gov Identifier: NCT00549809     History of Changes
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
mechanical ventilation; respiratory failure

Study placed in the following topic categories:
Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 07, 2009