Heart Rate Variability During Weaning From Mechanical Ventilation
| Tracking Information | |||||
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| First Received Date ICMJE | February 25, 2009 | ||||
| Last Updated Date | May 7, 2009 | ||||
| Start Date ICMJE | March 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
heart rate variability analysis [ Time Frame: minutes ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00851825 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Cardiorespiratory variables [ Time Frame: minutes ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Cardiorrespiratory variables [ Time Frame: minutes ] [ Designated as safety issue: Yes ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Heart Rate Variability During Weaning From Mechanical Ventilation | ||||
| Official Title ICMJE | The Effect of T-Tube and Pressure Support on Cardiorespiratory Variables and Heart Rate Variability During Weaning From Mechanical Ventilation | ||||
| 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. |
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| Detailed 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00851825 | ||||
| Other Study ID Numbers ICMJE | 03-435 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Silvia Regina Rios Vieira, Hospital de Clinicas de Porto Alegre | ||||
| Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital de Clinicas de Porto Alegre | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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