Sedation and Ventilator Weaning Protocol in PICU

University of Indonesia (UI)

Status: Active, not recruiting

Conditions: Sedation; Mechanical Ventilation

Treatments: Other: Sedation and ventilator weaning protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04788589

20030379

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient who need mechanical ventilation for more than 12 hours

Exclusion criteria

• PICU admission due to post cardiac and respiratory arrest

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Sedation and Ventilator Weaning Protocol

Experimental group

Description:

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.

Treatment:

Other: Sedation and ventilator weaning protocol

Control

No Intervention group

Description:

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.