CClinicalTrials.gg
CompletedNCT00549809Updated Jul 2, 2008

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

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

Phase
Phase 3
Study type
Interventional
Enrollment
70
Ages
28 Days to 4 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Failure

Keywords

  • mechanical ventilation; respiratory failure
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 70 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

UPECLIN HC FM Botucatu Unesp is the lead sponsor of 63 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days to 4 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    IMV, SIMV

    Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV

Interventions

  • ProcedureIntermittent 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)

06

What researchers measure

Primary outcomes

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

    Time frame: 2 years

07

Study locations

1 site
  • Jose Roberto Fioretto
    Botucatu, Sao Paulo 18.618-000, Brazil
08

References and documents

Publications

  • Moraes MA, Bonatto RC, Carpi MF, Ricchetti SM, Padovani CR, Fioretto JR. Comparison between intermittent mandatory ventilation and synchronized intermittent mandatory ventilation with pressure support in children. J Pediatr (Rio J). 2009 Jan-Feb;85(1):15-20. doi: 10.2223/JPED.1849. Epub 2008 Nov 6. English, Portuguese. PubMed 18989547 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00549809
Lead sponsor
UPECLIN HC FM Botucatu Unesp
First posted
Oct 26, 2007
Start date
Oct 2005
Primary completion
Feb 2007
Completion
Jun 2007
Last update
Jul 2, 2008

Study contacts

Jose R Fioretto, MD, PhD
principal investigator · UNESP - Botucatu Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion