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Completed

NCT Number: NCT00549809

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

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.

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Key information

Age range

28 day–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jose Roberto Fioretto

Botucatu, São Paulo, 18.618-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intermittent mandatory ventilation (IMV) and synchronous IMV

Procedure

Patients divided to receive two different modes of mechanical ventilation.

Other names: IMV (intermittent mandatory ventilation), SIMV (synchronous intermittent mandatory ventilation)

Primary outcomes

  1. duration of mechanical ventilation/weaning and length of stay in PICU

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

UPECLIN HC FM Botucatu Unesp

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 26, 2007
Registry last updated
Jul 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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