Sedation and Ventilator Weaning Protocol in PICU

• ClinicalTrials.gov Identifier: NCT04788589
• Recruitment Status: Recruiting
• First Posted: March 9, 2021
• Last Update Posted: March 12, 2021
• Sponsor: Indonesia University
• Information provided by (Responsible Party): Dr. dr. Antonius Hocky Pudjiadi, SpA(K), Indonesia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mechanical Ventilation; Sedation	Other: Sedation and ventilator weaning protocol	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Sedation and Ventilator Weaning Protocol - a Randomized Controlled Trial
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: September 1, 2021
• Estimated Study Completion Date: December 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0 [ Time Frame: 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. ]
   Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
2. Face, Leg, Activity, Cry, Consolability (FLACC) score hour 6 [ Time Frame: 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. ]
   Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
3. Face, Leg, Activity, Cry, Consolability (FLACC) score hour 12 [ Time Frame: 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. ]
   Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
4. Face, Leg, Activity, Cry, Consolability (FLACC) score hour 18 [ Time Frame: 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. ]
   Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
5. Face, Leg, Activity, Cry, Consolability (FLACC) score day 1 until extubation [ Time Frame: 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. ]
   Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
6. Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day [ Time Frame: 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. ]
   Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
7. COMFORT score hour 0 [ Time Frame: This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted. ]
   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
8. COMFORT score hour 6 [ Time Frame: 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. ]
   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
9. COMFORT score hour 12 [ Time Frame: 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. ]
   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
10. COMFORT score hour 18 [ Time Frame: 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. ]
    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
11. COMFORT score day 1 until extubation [ Time Frame: 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. ]
    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
12. COMFORT score extubation day [ Time Frame: 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. ]
    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
13. Ventilator time [ Time Frame: 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. ]
    Time to extubation (days)

Secondary Outcome Measures :

1. Reintubation frequency [ Time Frame: 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. ]
   Number of times subject was reintubated within 48 hours after extubation
2. Self extubation frequency [ Time Frame: 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. ]
   Number of times subject was self extubated during one episode of intubation
3. PICU length of stay [ Time Frame: 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. ]
   Days from PICU admission to death or move outside the PICU to the ward

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patient who need mechanical ventilation for more than 12 hours

Exclusion Criteria:

• PICU admission due to post cardiac and respiratory arrest

Contacts and Locations

Contacts

Contact: Gryselda Hanafi, MD; 628170113134; gryseldahanafi@gmail.com

Contact: Antonius Hocky Pudjiadi, MD, PhD; ahpdujiadi@gmail.com

Locations

Indonesia

Cipto Mangunkusumo Hospital; Recruiting

Jakarta Pusat, DKI Jakarta, Indonesia, 10430

Contact: Gryselda Hanafi, MD 628170113134 gryseldahanafi@gmail.com

Contact: Antonius H Pudjiadi, MD, PhD ahpudjiadi@gmail.com

Principal Investigator: Antonius H Pudjiadi, MD, PhD

Sub-Investigator: Tartila Tartila, MD

Sub-Investigator: Fatima Safira Alatas, MD, PhD

Sponsors and Collaborators

Indonesia University

More Information

• Responsible Party: Dr. dr. Antonius Hocky Pudjiadi, SpA(K), Principal Investigator, Head of Pediatric Intensive Care Unit, Indonesia University
• ClinicalTrials.gov Identifier: NCT04788589
• Other Study ID Numbers: 20030379
• First Posted: March 9, 2021
• Last Update Posted: March 12, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No