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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00851825
Other study ID # 03-435
Secondary ID
Status Completed
Phase N/A
First received February 25, 2009
Last updated May 7, 2009
Start date March 2003
Est. completion date June 2007

Study information

Verified date May 2009
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial 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.


Description:

Thirty patients who had received MV for ≥ 48 hours and who met the criteria for weaning were assessed. Two different weaning methods were used and randomization was performed to choose one of the following sequences (baseline, PSV, rest, TT; or baseline, TT, rest, PSV). HRV was assessed by heart rate spectral analysis during MV, PSV, and TT. Each intervention lasted 30 minutes and there was a 30-minute rest period between the interventions. At the end of each period of time, the following cardiorespiratory variables were analyzed: respiratory rate (f), minute ventilation (VE), tidal volume (VT), rapid shallow breathing index (f/VT), peripheral oxygen saturation (SpO2), heart rate (HR) and blood pressure. In the HRV, the total spectral power (TP), the low frequency (LF) and the high frequency (HF) components, and the ratio between the low/high frequency (LF/HF) components were calculated.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

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

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Brazil Federal University of Rio Grande do Sul Porto Alegre RS

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary heart rate variability analysis minutes Yes
Secondary Cardiorespiratory variables minutes Yes
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