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
  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:


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
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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 July 20, 2014