NCT00549809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed
Last Updated

July 2, 2008

Status Verified

June 1, 2008

Enrollment Period

1.3 years

First QC Date

October 25, 2007

Last Update Submit

June 27, 2008

Conditions

Respiratory Failure

Keywords

mechanical ventilation; respiratory failure

Outcome Measures

Primary Outcomes (1)

  • duration of mechanical ventilation/weaning and length of stay in PICU

    2 years

Study Arms (1)

IMV, SIMV

ACTIVE COMPARATOR
Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV

Interventions

Intermittent mandatory ventilation (IMV) and synchronous IMVPROCEDURE

Patients divided to receive two different modes of mechanical ventilation.

Also known as: IMV (intermittent mandatory ventilation), SIMV (synchronous intermittent mandatory ventilation)
IMV, SIMV

Eligibility Criteria

Age28 Days - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 28 days and four years, who were consecutively admitted to the PICU and required MV for more than 48h were included.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jose Roberto Fioretto

Botucatu, São Paulo, 18.618-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 18989547DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Jose R Fioretto, MD, PhD

    UNESP - Botucatu Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 26, 2007

Study Start

October 1, 2005

Primary Completion

February 1, 2007

Study Completion

June 1, 2007

Last Updated

July 2, 2008

Record last verified: 2008-06

Locations

BR(1)