MedDataX Logo

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

NCT ID: NCT00549809

Last Updated: 2008-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

mechanical ventilation; respiratory failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IMV, SIMV

Group Type ACTIVE_COMPARATOR

Intermittent mandatory ventilation (IMV) and synchronous IMV

Intervention Type PROCEDURE

Patients divided to receive two different modes of mechanical ventilation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intermittent mandatory ventilation (IMV) and synchronous IMV

Patients divided to receive two different modes of mechanical ventilation.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

IMV (intermittent mandatory ventilation) SIMV (synchronous intermittent mandatory ventilation)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

28 Days

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

UNESP - Botucatu Medical School

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jose R Fioretto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UNESP - Botucatu Medical School

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jose Roberto Fioretto

Botucatu, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 18989547 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

upeclin/HC/FMB-Unesp-04

Identifier Type: -

Identifier Source: org_study_id