Predictive Analysis Software for Successful Weaning From Ventilator of Patients

NCT02915458 | Unknown

• 1 other identifier: 104-6531B
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning Failure

Keywords

Weaning; Mechanical ventilation; synchrosqueezing transform

Outcome Measures

Primary Outcomes (1)

• Successful weaning from mechanical ventilation

  The patients could breath by themselves after extubation without any ventilator assistance for 72 hours

  up to 72 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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:
• clear improvement of the condition that led to mechanical ventilation;
• no acute pulmonary or neuromuscular disease or signs of increased intracranial pressure;
• conscious and lying on a bed with the upper body elevated to a 30◦ angle
• 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);
• no significant respiratory acidosis, PaCO2\<50mmHg, or increasing \<10% for patients with chronic CO2 retention.
• stable cardiovascular status (Heat beat ≤140/min, systolic blood pressure 90-160mmHg);
• no requirement for vasopressive or inotropic dugs≥ 8 hours;
• no intravenous sedatives during the previous 24 hours;
• ability to cough while suction;
• afebrile with ≤ 38◦ C temperature.
• negative cuff leakage test: \>110ml or \>12%

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

RECRUITING

Related Publications (2)

• Wu HT, Talmon R, Lo YL. Assess sleep stage by modern signal processing techniques. IEEE Trans Biomed Eng. 2015 Apr;62(4):1159-1168. doi: 10.1109/TBME.2014.2375292. Epub 2014 Nov 26.

  PMID: 25438301 BACKGROUND

• Wu HT, Hseu SS, Bien MY, Kou YR, Daubechies I. Evaluating physiological dynamics via synchrosqueezing: prediction of ventilator weaning. IEEE Trans Biomed Eng. 2014 Mar;61(3):736-44. doi: 10.1109/TBME.2013.2288497. Epub 2013 Nov 4.

  PMID: 24235294 BACKGROUND

Study Officials

• Yu-Lun Lo, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting-Yu Lin, MD

CONTACT

886-3-3281200; yuebaoyuebao@gmail.com

Yu-Lun Lo, MD

CONTACT

886-3-3281200; loyulun@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: September 27, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

TW (1)