Trial Outcomes & Findings for Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation (NCT NCT00606554)

NCT ID: NCT00606554

Last Updated: 2017-12-11

Results Overview

Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Continuous (median weaning duration was 2 days)
• Results posted on: 2017-12-11

Participant Flow

Recruitment start 1/2008 recruitment end: 5/2010 Recruited from Medical Intensive Care Unites Boston medical Center

Participant milestones

Measure	Computer-assisted Wean Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Overall Study STARTED	15	18
Overall Study COMPLETED	15	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation

Baseline characteristics by cohort

Measure	Computer-assisted Wean n=15 Participants Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 Participants Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group	Total n=33 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 21 • n=5 Participants	60.5 years STANDARD_DEVIATION 15.5 • n=7 Participants	55.7 years STANDARD_DEVIATION 18.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
APACHE II Score	23.3 score STANDARD_DEVIATION 7.7 • n=5 Participants	26.5 score STANDARD_DEVIATION 7.1 • n=7 Participants	25 score STANDARD_DEVIATION 7.4 • n=5 Participants

PRIMARY outcome

Timeframe: Continuous (median weaning duration was 2 days)

Population: ITT

Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.

Outcome measures

Measure	Computer-assisted Wean n=15 Participants Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 Participants Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Duration of Weaning	1.92 Days Interval 0.98 to 4.78	2.15 Days Interval 0.92 to 9.1

SECONDARY outcome

Timeframe: from start of weaning to discharge from ICU, on average 1-2 weeks

Duration of ICU stay after weaning initiation

Outcome measures

Measure	Computer-assisted Wean n=15 Participants Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 Participants Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Duration of ICU Stay	10.2 days Interval 7.6 to 19.7	15 days Interval 7.9 to 20.3

SECONDARY outcome

Timeframe: from start of weaning to liberation from ventilator, on average 1-2 days

Duration of mechanical ventilation from weaning initiation

Outcome measures

Measure	Computer-assisted Wean n=15 Participants Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 Participants Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Duration of Mechanical Ventilation	1.91 days Interval 0.98 to 4.78	2.15 days Interval 0.92 to 9.1

SECONDARY outcome

Timeframe: from start of weaning to discharge from hospital, on average 1-2 weeks

Outcome measures

Measure	Computer-assisted Wean n=15 Participants Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 Participants Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Duration of Hospitalization	19.1 days Interval 11.1 to 27.8	19.7 days Interval 15.7 to 25.4

SECONDARY outcome

Timeframe: 28 days

Population: ITT

proportion of patients in each arm who died in the hospital

Outcome measures

Measure	Computer-assisted Wean n=15 Participants Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 Participants Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Inpatient Mortality	1 Participants	6 Participants

SECONDARY outcome

Timeframe: during weaning, on average 1-2 days

Population: Data were not recorded

measure was not recorded

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from start of weaning to liberation from ventilator, on average 1-2 days

Outcome measures

Measure	Computer-assisted Wean n=15 Participants Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 Participants Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Number of Spontaneous Breathing Trials Prior to Extubation	0 SBTs Interval 0.0 to 1.0	1 SBTs Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Duration of weaning (median 2 days)

Population: Number of participants with adverse event during weaning

This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.

Outcome measures

Measure	Computer-assisted Wean n=15 Participants Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 Participants Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)	7 Participants	8 Participants

Adverse Events

Computer-assisted Wean

Serious events: 7 serious events

Other events: 1 other events

Deaths: 1 deaths

Standard of Care

Serious events: 8 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Measure	Computer-assisted Wean n=15 participants at risk Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 participants at risk Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Respiratory, thoracic and mediastinal disorders Need for Tracheostomy	13.3% 2/15 • Number of events 2 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days	0.00% 0/18 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days
Infections and infestations Ventilator associated pneumonia	6.7% 1/15 • Number of events 1 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days	11.1% 2/18 • Number of events 2 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days
Respiratory, thoracic and mediastinal disorders Death during weaning process	0.00% 0/15 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days	16.7% 3/18 • Number of events 3 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days
Respiratory, thoracic and mediastinal disorders Re-intubation	26.7% 4/15 • Number of events 4 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days	22.2% 4/18 • Number of events 4 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days
Respiratory, thoracic and mediastinal disorders Self-extubation	0.00% 0/15 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days	5.6% 1/18 • Number of events 1 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days
Respiratory, thoracic and mediastinal disorders Non-invasive ventilation	13.3% 2/15 • Number of events 2 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days	22.2% 4/18 • Number of events 4 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days

Other adverse events

Measure	Computer-assisted Wean n=15 participants at risk Group assigned to the computer-assisted weaning program Intervention Group	Standard of Care n=18 participants at risk Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
Respiratory, thoracic and mediastinal disorders High pressure support level reached	6.7% 1/15 • Number of events 1 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days	0.00% 0/18 • Duration of hospitalization after initiation of mechanical ventilation. Median 20 days

Additional Information

Allan Walkey, MD, MSc

Boston University School of Medicine

Phone: 617-638-4860

Email: alwalkey@bu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place