Sedation and Ventilator Weaning Protocol in PICU

Effectiveness of Sedation and Ventilator Weaning Protocol - a Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sedation; Mechanical Ventilation
• Intervention / Treatment: Other: Sedation and ventilator weaning protocol

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient who need mechanical ventilation for more than 12 hours

Exclusion Criteria:

• PICU admission due to post cardiac and respiratory arrest

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sedation and Ventilator Weaning Protocol; 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; Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.
No Intervention: Control; Informed consent; Randomization into groups; Sedation and ventilator weaning according to attending physicians; 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.; Attending physicians assessed that subject could be weaned: pain scores, SBS score, WAT-1 score; Extubation. Researcher did not take part in the judgement of extubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintubation frequency	Number of times subject was reintubated within 48 hours after extubation	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	Number of times subject was self extubated during one episode of intubation	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	Days from PICU admission to death or move outside the PICU to the ward	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	Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury.	The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-1	Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury.	The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-6	Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury.	The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-12	Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury.	The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation.
Inotropic intervention	All inotropes used will be noted as secondary outcome to identify the hypotensive and/or bradycardia complications that might be caused due to usage of sedatives and analgesia. The usage will be divided into two categories: Yes and No usage of inotrope	The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days.
Vasoactive-Inotropic Score	The VIS were extracted from the formula: dopamine dose (μg/kg/minute) + dobutamine dose (μg/kg/minute) + 100 x epinephine dose (μg/kg/minute) + 10 x milrinone dose (μg/kg/minute) + 10,000 x vasopressine dose (unit/kg/minute) + 100 x norepinefrine dose (μg/kg/minute). The VIS score was categorized into two (≥20 dan <20).	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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Antonius H. Pudjiadi, MD, PhD, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20030379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No