NCT00851825

Brief Summary

The discontinuation of mechanical ventilation (MV) and the recovery of spontaneous breathing can lead to important cardiovascular alterations due to changes in the intrathoracic pressure. The autonomic modulation assessed through heart rate variability (HRV) during weaning from MV and its impact on cardiorespiratory variables has not been well elucidated yet. To evaluate the effect of T-tube (TT) and pressure support ventilation (PSV) during weaning from MV on cardiorespiratory variables and heart rate variability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
Last Updated

May 8, 2009

Status Verified

May 1, 2009

First QC Date

February 25, 2009

Last Update Submit

May 7, 2009

Conditions

Keywords

autonomic modulationheart ratepressure support ventilationT-tubeMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • heart rate variability analysis

    minutes

Secondary Outcomes (1)

  • Cardiorespiratory variables

    minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with respiratory failure receiving MV for more than 48 hours, who had been admitted to the Intensive Care Unit (ICU) of the Hospital de Clínicas de Porto Alegre, and who met the criteria for weaning from MV according to the parameters previously defined were selected to participate in this study.

You may qualify if:

  • Patients with respiratory failure receiving MV for more than 48 hours
  • for weaning from MV according to the parameters previously defined were selected to participate in this study

You may not qualify if:

  • arterial hypotension (systolic blood pressure \< 100mmHg), severe brain disease, barotraumas, presence of thoracic drain or tracheostomy, using vasoactive and sedative drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Study Officials

  • Silvia R Veira, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

March 1, 2003

Study Completion

June 1, 2007

Last Updated

May 8, 2009

Record last verified: 2009-05

Locations