Clinical trial NCT02915458: Predictive Analysis Software for Successful Weaning From Ventilator of Patients
Official title: Predictive Analysis Software for Successful Weaning From Ventilator of Patients in Critical Condition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weaning Failure
Keywords: Weaning
Mechanical ventilation
synchrosqueezing transform
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Successful weaning from mechanical ventilation
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu-Lun Lo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.