Sedation and Ventilator Weaning Protocol in PICU

NCT04788589 | Unknown

• 1 other identifier: 20030379
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Sedation

Outcome Measures

Primary Outcomes (13)

• Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0

  Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.

  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.

• Face, Leg, Activity, Cry, Consolability (FLACC) score hour 6

  Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.

  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.

• Face, Leg, Activity, Cry, Consolability (FLACC) score hour 12

  Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.

  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.

• Face, Leg, Activity, Cry, Consolability (FLACC) score hour 18

  Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.

  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.

• Face, Leg, Activity, Cry, Consolability (FLACC) score day 1 until extubation

  Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.

  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.

• Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day

  Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.

  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.

• COMFORT score hour 0

  Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated

  This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted.

• COMFORT score hour 6

  Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated

  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.

• COMFORT score hour 12

  Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated

  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.

• COMFORT score hour 18

  Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated

  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.

• COMFORT score day 1 until extubation

  Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated

  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.

• COMFORT score extubation day

  Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated

  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.

• Ventilator time

  Time to extubation (days)

  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 (9)

• Reintubation frequency

  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.

• Self extubation frequency

  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.

• PICU length of stay

  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.

• Near infrared spectroscopy minute 5

  The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.

• Near infrared spectroscopy hour-1

  The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.

Study Arms (2)

Sedation and Ventilator Weaning Protocol

EXPERIMENTAL

Sedation: start midazolam 5-10 mins (max 3x). If MV 12 hrs-2d: Pain: morphine @2 hrs if needed (max 10mg/x). Sedation: midazolam @ 1-2 hrs if needed (max 10mg/x). If MV \>2 d: morphine \& midazolam drip (max 10mg/hr). MV weaning checklist @morning. Pass if no incr of sedation dose due to agitation, NMBAs, incr in ICP. Fail: reassessed tomorrow. Pain and SBS scores assessed @morning until extubation. Stop all sedation and analgetic for sedation. Continue analgetics for pain. Subjects monitored for 4 hrs. Assess pain and WAT-1 score. Pass (GCS of E3, tolerate sedation interruption for \> 4 hrs): MV weaning protocol. Fail (Persistent anxiety/agitation, incr pain score, incr RR \> 5 mins, SpO2 \<88% \>5 mins, acute heart dysrhythmia, \>=2 signs of ARDS): sedation resumed ½ dose, up titrated. MV weaning: CPAP 5/PS \< 7. Pass: No failure criteria for 2 hrs. Fail (Incr RR \> 5 mins, SpO2 \<88% \> 5 mins, acute decr in GCS/acute heart dysrhythmia, \>=2 signs of ARDS): previous MV setting.

Other: Sedation and ventilator weaning protocol

Control

NO INTERVENTION

1. Informed consent 2. Randomization into groups 3. Sedation and ventilator weaning according to attending physicians 4. Pain scores and SBS score is noted every 6 hours for the first 24 hours, and every day for the next 24 hours until extubation. 5. Attending physicians assessed that subject could be weaned: pain scores, SBS score, WAT-1 score 6. Extubation. Researcher did not take part in the judgement of extubation.

Interventions

Sedation and ventilator weaning protocol OTHER

Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.

Sedation and Ventilator Weaning Protocol

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient who need mechanical ventilation for more than 12 hours

You may not qualify if:

• PICU admission due to post cardiac and respiratory arrest

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

• Antonius H. Pudjiadi, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Pediatric Intensive Care Unit

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: March 9, 2021
• Study Start: September 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)