A Phase 3 interventional study of Intermittent mandatory ventilation (IMV) and synchronous IMV in Respiratory Failure, sponsored by UPECLIN HC FM Botucatu Unesp. Completed at 1 site in Brazil. Open to participants aged 28 Days to 4 Years. Per ClinicalTrials.gov, last updated 2008-07-02.
Sponsored by UPECLIN HC FM Botucatu Unesp · Phase 3, Interventional, and Treatment
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.
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This study's enrollment of 70 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
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Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV
Patients divided to receive two different modes of mechanical ventilation.
Also known as: IMV (intermittent mandatory ventilation), SIMV (synchronous intermittent mandatory ventilation)
duration of mechanical ventilation/weaning and length of stay in PICU
Time frame: 2 years
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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UPECLIN HC FM Botucatu Unesp