Clinical Trials Directory

Trials / Completed

CompletedNCT00549809

Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
70 (actual)
Sponsor
UPECLIN HC FM Botucatu Unesp · Academic / Other
Sex
All
Age
28 Days – 4 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREIntermittent mandatory ventilation (IMV) and synchronous IMVPatients divided to receive two different modes of mechanical ventilation.

Timeline

Start date
2005-10-01
Primary completion
2007-02-01
Completion
2007-06-01
First posted
2007-10-26
Last updated
2008-07-02

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT00549809. Inclusion in this directory is not an endorsement.