Clinical trial NCT04788589: Sedation and Ventilator Weaning Protocol in PICU
Official title: Effectiveness of Sedation and Ventilator Weaning Protocol - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation
Sedation
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is a single-blinded, randomized controlled trial involving mechanically ventilated children in Pediatric Intensive Care Unit, Cipto Mangunkusumo Hospital, Indonesia. Subjects were divided into two groups: intervention vs control group. Primary and secondary outcomes will be measure pre, during, and post treatment.

Detailed description: As of today, there is no sedation and ventilator weaning protocol in our PICU. Decision for sedation and ventilator weaning were based on attending physicians clinical judgement, which greatly varies among individual. Previous study on the use of these protocols showed a favorable outcome. We aim to assess the safety and effectiveness of this protocol in our PICU.

Subjects were recruited consecutively and randomized into intervention and control group.

* Intervention group: sedation and ventilator weaning protocol
* Control group: no protocol

Primary outcomes:

* FLACC score
* COMFORT score
* Ventilator days

Secondary outcomes:

* Self extubation
* Reintubation
* PICU Length of stay
* Frequency of asynchrony
* NIRS value
* VIS score

Eligibility criteria: Inclusion Criteria:

* Patient who need mechanical ventilation for more than 12 hours

Exclusion Criteria:

* PICU admission due to post cardiac and respiratory arrest

Primary outcomes:
measure: Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
timeFrame: every 6 hours for the first 24 hours, once daily until extubation. This is the baseline. Once the patient was intubated, FLACC scoring of hour 0 will be assessed and noted.
measure: Face, Leg, Activity, Cry, Consolability (FLACC) score hour 6
timeFrame: FLACC scoring of hour 6 will be measured 6 hours after hour 0 was measured. Hour 6 is measured from the time the subject was intubated.
measure: Face, Leg, Activity, Cry, Consolability (FLACC) score hour 12
timeFrame: FLACC scoring of hour 12 will be measured 12 hours after hour 0 was measured. Hour 12 is measured from the time the subject was intubated.
measure: Face, Leg, Activity, Cry, Consolability (FLACC) score hour 18
timeFrame: FLACC scoring of hour 18 will be measured 18 hours after hour 0 was measured. Hour 18 is measured from the time the subject was intubated.
measure: Face, Leg, Activity, Cry, Consolability (FLACC) score day 1 until extubation
timeFrame: Scoring will be assessed every morning. If the subject was intubated at night, scoring for day 1 will be measured in the morning the day after tomorrow. Thereafter, the measurement will be taken every morning, 24 hour apart until the subject extubation.
measure: Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day
timeFrame: This score will be taken when the subject was stopped from all sedative and analgetics, just before extubation. Monitoring of extubation will be conducted until 56 days after initial intubation.
measure: COMFORT score hour 0
timeFrame: This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted.
measure: COMFORT score hour 6
timeFrame: COMFORT scoring of hour 6 will be measured 6 hours after hour 0 was measured. Hour 6 is measured from the time the subject was intubated.
measure: COMFORT score hour 12
timeFrame: COMFORT scoring of hour 12 will be measured 12 hours after hour 0 was measured. Hour 12 is measured from the time the subject was intubated.
measure: COMFORT score hour 18
timeFrame: COMFORT scoring of hour 18 will be measured 18 hours after hour 0 was measured. Hour 18 is measured from the time the subject was intubated.
measure: COMFORT score day 1 until extubation
timeFrame: Scoring will be assessed every morning. If the subject was intubated at night, scoring for day 1 will be measured in the morning the day after tomorrow. Thereafter, the measurement will be taken every morning, 24 hour apart until the subject extubation.
measure: COMFORT score extubation day
timeFrame: This score will be taken when the subject was stopped from all sedative and analgetics, just before extubation. Monitoring of extubation will be conducted until 56 days after initial intubation.
measure: Ventilator time
timeFrame: From intubation to extubation which would not need reintubation within 48 hours of extubation, measurement of the time frame may be assessed up to 28 days measured from intubation time.
Secondary outcomes:
measure: Reintubation frequency
timeFrame: Frequency of subject who are extubated to be reintubated within 48 hours after extubation. Assessment will be noted up to 28 days measured from the first time intubation was performed.
measure: Self extubation frequency
timeFrame: Frequency of self extubation by the patient during one episode of intubation. Assessment will be noted up to 28 days measured from the first time intubation was performed.
measure: PICU length of stay
timeFrame: Length of stay in PICU from admission until patient's death or step-down to the pediatric ward. Assessment of PICU length of stay will be noted up to 56 days measured from the first day of PICU admission as day 1.
measure: Near infrared spectroscopy minute 5
timeFrame: The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.
measure: Near infrared spectroscopy hour-1
timeFrame: The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.
measure: Near infrared spectroscopy hour-6
timeFrame: The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation.
measure: Near infrared spectroscopy hour-12
timeFrame: The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation.
measure: Inotropic intervention
timeFrame: The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days.
measure: Vasoactive-Inotropic Score
timeFrame: The VIS score will be measured once during PICU admission up to 14 days of mechanical ventilation days.. The highest value will be recorded and categorized into two groups
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Antonius H. Pudjiadi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: