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Sponsored by: |
UPECLIN HC FM Botucatu Unesp |
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Information provided by: | UPECLIN HC FM Botucatu Unesp |
ClinicalTrials.gov Identifier: | NCT00549809 |
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 |
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Respiratory Failure |
Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV |
Phase III |
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 |
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 |
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IMV, SIMV: Active Comparator |
Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV
Patients divided to receive two different modes of mechanical ventilation.
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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.
Ages Eligible for Study: | up to 4 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, Sao Paulo | |
Jose Roberto Fioretto | |
Botucatu, Sao Paulo, Brazil, 18.618-000 |
Principal Investigator: | Jose R Fioretto, MD, PhD | UNESP - Botucatu Medical School |
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 |
mechanical ventilation; respiratory failure |
Respiratory Insufficiency Respiratory Tract Diseases Respiration Disorders |
Respiratory Insufficiency Respiratory Tract Diseases Respiration Disorders |