Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788589
Status:
UNKNOWN
Last Update Posted:
2022-06-14
First Post:
2021-02-13
Brief Title:
Sedation and Ventilator Weaning Protocol in PICU
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Effectiveness of Sedation and Ventilator Weaning Protocol - a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None