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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00549809
Enrollment
70
Registered
2007-10-26
Start date
2005-10-31
Completion date
2007-06-30
Last updated
2008-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

mechanical ventilation; respiratory failure

Brief 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.

Interventions

PROCEDUREIntermittent mandatory ventilation (IMV) and synchronous IMV

Patients divided to receive two different modes of mechanical ventilation.

Sponsors

UPECLIN HC FM Botucatu Unesp
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
28 Days to 4 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
duration of mechanical ventilation/weaning and length of stay in PICU2 years

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026