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NCT01237886 · ClinicalTrials.gov registry record

Weaning And Variability Evaluation

A clinical trial, sponsored by Ottawa Hospital Research Institute.

Completed
Registry status
660
Enrollment target

NCT01237886: Completed study, sponsored by Ottawa Hospital Research Institute.

NCT01237886 is a clinical trial that has completed, run by Ottawa Hospital Research Institute. The registered enrollment target is 660 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01237886 has completed, sponsored by Ottawa Hospital Research Institute.

COMPLETED
Registry status
660 participants
Enrollment target

Study Summary

Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or endotracheal tube or extubation) is critically important, as both prolonged ventilation and failed extubation are both associated with harm and risk of death. Our objective is to improve the safety of extubation by harnessing hidden information contained in the patterns of variation of heart and respiratory rate measured over intervals-in-time. Currently, to assess a patient's ability to be extubated, a spontaneous breathing trial (SBT) is routinely performed, where the level of ventilator support is reduced, and their response is observed in order to help predict if they will tolerate extubation (i.e. complete removal of ventilator support). Given that health is associated with a high degree of variation of physiologic parameters (e.g. heart and respiratory rate), and illness \& stress are associated with a loss of variability, the investigators aim to uncover the loss of variation as a measure of stress during SBT's. The investigators hypothesize that maintaining stable heart rate and respiratory rate variability (HRV and RRV) throughout the SBT will predict subsequent successful extubation, and conversely, a reduction in either HRV or RRV manifest during a SBT predicts extubation failure. A pilot study has demonstrated feasibility, and compelling preliminary results. A website, centralized data storage and analysis, and a trans-disciplinary team of scientists are in place to definitively test this novel technology. Determination of when to extubate critically ill patients remains a high-stakes clinical challenge; and improved prediction of extubation failure has potential to save lives and reduce costs in critically ill patients.

Trial Details

FieldValue
Enrollment Target 660 participants
Start Date 2009-11
Est. Completion 2012-11

What the finished NCT01237886 record still lists

NCT01237886 is an observational study that tracks outcomes without assigning an intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01237886 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01237886 about?

NCT01237886 is a clinical study titled "Weaning And Variability Evaluation". Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or endotracheal tube or extubation) is critically important, as both prolonged ventilation and failed extubation are both associated with harm and risk of death. Our objective is to improve the safety of extubat...

What is the current status of trial NCT01237886?

This trial is currently completed. The enrollment target is 660 participants. The study started on 2009-11. Estimated completion is 2012-11.

Who is sponsoring clinical trial NCT01237886?

This trial is sponsored by Ottawa Hospital Research Institute, which has 8 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01237886, the US trial registry maintained by the National Library of Medicine. NCT01237886 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.