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Predictive Analysis Software for Successful Weaning From Ventilator of Patients

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ClinicalTrials.gov Identifier: NCT02915458
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Yu-Lun Lo, Chang Gung Memorial Hospital

Brief Summary:

Making a weaning decision for a patient on a mechanical ventilator is an important clinical issue. The most common index to predict successful weaning is the rapid shallow breathing index (RSBI), however, the accuracy of RSBI to predict successful weaning have been questioned.

The investigators proposed a new mathematical model and algorithm, called WIN, which capture the essential feature of the variability ruling the physiological dynamics to provides better perdition to wean than RSBI.


Condition or disease
Weaning Failure

Detailed Description:

Making a weaning decision for a patient on a mechanical ventilator is an important clinical issue.

It is thus important to decide accurately when patients can be weaned from the ventilator. To increase the weaning success, the present common practice is to conduct spontaneous breathing trials to get physiological signals that may provide the information about capacity of successful weaning. The most common index is the rapid shallow breathing index (RSBI), however, the accuracy of RSBI to predict successful weaning have been questioned. Weaning failure usually results from a complex interplay of multiple factors. Thus, predictors targeting a single pathophysiologic mechanism tend to be unreliable for heterogeneous abnormalities.

The investigators proposed a new mathematical model and algorithm, which capture the essential feature of the variability ruling the physiological dynamics. Through the modern adaptive signal processing techniques, the investigators develop an index called WIN, which is evaluated from the 5 minutes continuous physiological signal and provides better perdition to wean than RSBI in a retrospective analysis. In this study, the investigators evaluate the predictive power of WIN and RSBI prospectively in patients undergoing weaning prospectively.


Study Type : Observational
Estimated Enrollment : 188 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Predictive Analysis Software for Successful Weaning From Ventilator of Patients in Critical Condition
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. Successful weaning from mechanical ventilation [ Time Frame: up to 72 hours ]
    The patients could breath by themselves after extubation without any ventilator assistance for 72 hours



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients with mechanical ventilation via an endotracheal tube (oral endotracheal tube or tracheostomy tube) for >24 hours;
  2. Patients are ready be weaned to performed a spontaneous breathing trial by 120-min T-piece.
Criteria

Inclusion Criteria:

1. Patients with mechanical ventilation via an endotracheal tube (oral endotracheal tube or tracheostomy tube) for >24 hours; 2. Patients are concomitant with presence of the following criteria of ready be weaned, a spontaneous breathing trial (SBT) will then be evaluated by 120-min T-piece:

  1. clear improvement of the condition that led to mechanical ventilation;
  2. no acute pulmonary or neuromuscular disease or signs of increased intracranial pressure;
  3. conscious and lying on a bed with the upper body elevated to a 30◦ angle
  4. adequate oxygenation (PaO2 ≥ 60mmHg and fraction of inspired oxygen inspired oxygen fraction (FiO2) ≤ 40% with positive end expiratory pressure (PEEP) ≤ 8cm H2O, or PaO2 /FiO2 >150 mmHg);
  5. no significant respiratory acidosis, PaCO2<50mmHg, or increasing <10% for patients with chronic CO2 retention.
  6. stable cardiovascular status (Heat beat ≤140/min, systolic blood pressure 90-160mmHg);
  7. no requirement for vasopressive or inotropic dugs≥ 8 hours;
  8. no intravenous sedatives during the previous 24 hours;
  9. ability to cough while suction;
  10. afebrile with ≤ 38◦ C temperature.
  11. negative cuff leakage test: >110ml or >12%

Exclusion Criteria:

  1. Presence of tracheostomy
  2. Home ventilation prior to ICU admission
  3. Decision not to re-intubate or withdrawal of care anticipated
  4. Further surgery requiring sedation planned next 48 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915458


Contacts
Contact: Ting-Yu Lin, MD 886-3-3281200 ext 8468 yuebaoyuebao@gmail.com
Contact: Yu-Lun Lo, MD 886-3-3281200 ext 8467 loyulun@hotmail.com

Locations
Taiwan
Department of Thoracic Medicine, Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 33305
Contact: Ting-Yu Lin, MD    886-3-3281200 ext 5108    yuebaoyuebao@yahoo.com.tw   
Principal Investigator: Ting-Yu Lin, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yu-Lun Lo, MD Chang Gung Memorial Hospital

Publications:
Responsible Party: Yu-Lun Lo, Principal Investigator, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02915458     History of Changes
Other Study ID Numbers: 104-6531B
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yu-Lun Lo, Chang Gung Memorial Hospital:
Weaning
Mechanical ventilation
synchrosqueezing transform