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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
History of Changes
  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 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

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
Active Comparator: IMV, SIMV 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)

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
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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: José Roberto Fioretto, UNESP - Botucatu Medical School
ClinicalTrials.gov Identifier: NCT00549809     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-04
Study First Received: October 25, 2007
Last Updated: June 27, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on May 23, 2013