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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549809
• Other study ID #: upeclin/HC/FMB-Unesp-04
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2007
• Last updated: June 27, 2008
• Start date: October 2005
• Est. completion date: June 2007

Study information

• Verified date: June 2008
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Years

Eligibility

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).

Study Design

Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Intermittent mandatory ventilation (IMV) and synchronous IMV
Patients divided to receive two different modes of mechanical ventilation.

Locations

Country	Name	City	State
Brazil	Jose Roberto Fioretto	Botucatu	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of mechanical ventilation/weaning and length of stay in PICU		2 years	Yes