Trial Outcomes & Findings for Weaning From Mechanical Ventilation in Neurological Patients (NCT NCT03128086)

Results Overview

Rate of failure after extubation (increase of respiratory rate, deterioration of oxygenation, increase of cardiac rate or blood pressure)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

2 days after extubation

Results posted on

2020-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Protocol-directed Weaning A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
Overall Study STARTED	50	44
Overall Study COMPLETED	50	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Protocol-directed Weaning n=50 Participants A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning n=44 Participants A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=50 Participants	1 Participants n=44 Participants	3 Participants n=94 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=50 Participants	23 Participants n=44 Participants	54 Participants n=94 Participants
Age, Categorical >=65 years	17 Participants n=50 Participants	20 Participants n=44 Participants	37 Participants n=94 Participants
Age, Continuous	54 years STANDARD_DEVIATION 19 • n=50 Participants	58 years STANDARD_DEVIATION 19 • n=44 Participants	56 years STANDARD_DEVIATION 19 • n=94 Participants
Sex: Female, Male Female	20 Participants n=50 Participants	17 Participants n=44 Participants	37 Participants n=94 Participants
Sex: Female, Male Male	30 Participants n=50 Participants	27 Participants n=44 Participants	57 Participants n=94 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Spain	50 participants n=50 Participants	44 participants n=44 Participants	94 participants n=94 Participants

PRIMARY outcome

Timeframe: 2 days after extubation

Population: In conventional group, 9 participants were tracheostomized directly without previous extubation

Rate of failure after extubation (increase of respiratory rate, deterioration of oxygenation, increase of cardiac rate or blood pressure)

Outcome measures

Outcome measures
Measure	Protocol-directed Weaning n=50 Participants A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning n=35 Participants A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
Number of Participants With Extubation Failure	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Along intensive care unit stay (30 days)

Need for tracheostomy during process of weaning either before or after extubation

Outcome measures

Outcome measures
Measure	Protocol-directed Weaning n=50 Participants A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning n=44 Participants A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
Number of Participants With Need for Tracheostomy	4 Participants	11 Participants

SECONDARY outcome

Timeframe: Intensive Care unit stay (30 days)

Measure all the time (in days) the patient is connected to mechanical ventilation

Outcome measures

Outcome measures
Measure	Protocol-directed Weaning n=50 Participants A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning n=44 Participants A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
Duration of Mechanical Ventilation	5 days Interval 2.0 to 13.0	9 days Interval 3.0 to 22.0

SECONDARY outcome

Timeframe: days (30 days)

Measure length of stay at intensive care unit

Outcome measures

Outcome measures
Measure	Protocol-directed Weaning n=50 Participants A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning n=44 Participants A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
Intensive Care Unit Stay	9 days Interval 5.0 to 20.0	14 days Interval 6.0 to 29.0

SECONDARY outcome

Timeframe: days (2 months)

Measure length of stay at hospital

Outcome measures

Outcome measures
Measure	Protocol-directed Weaning n=50 Participants A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning n=44 Participants A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
Hospital Stay	24 days Interval 17.0 to 48.0	33 days Interval 19.0 to 52.0

SECONDARY outcome

Timeframe: Along intensive care unit stay (30 days)

Mortality at intensive care unit

Outcome measures

Outcome measures
Measure	Protocol-directed Weaning n=50 Participants A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning n=44 Participants A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
Intensive Care Unit Mortality	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Along hospital stay (2 months)

Mortality at hospital (including at intensive care unit)

Outcome measures

Outcome measures
Measure	Protocol-directed Weaning n=50 Participants A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning n=44 Participants A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
Hospital Mortality	5 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 months

Mortality at 90 days after inclusion at study

Outcome measures

Outcome measures
Measure	Protocol-directed Weaning n=50 Participants A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated. Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)	Conventional Weaning n=44 Participants A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
90-day Mortality	6 Participants	9 Participants

Adverse Events

Protocol-directed Weaning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Conventional Weaning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

DR. ALBERTO BELENGUER-MUNCHARAZ

HOSPITAL UNIVERSITARIO GENERAL DE CASTELLÓN, SPAIN. CONSELLERIA SANITAT

Phone: 964 72 50 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place