Health Condition 1: J969- Respiratory failure, unspecified
Conditions
Interventions
Intervention1: Dexmedetomidine: children randomized to this arm will be started on dexmedetomidine ( a sedo- analgesic agent) infusion @ 0.5mcg/kg/hour (@1ml/hour) , starting 4 to 12 hours prior to pl
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. mechanically ventilated for more than 48 hours 2. planned for extubation in next 12 to 24 hours
Exclusion criteria
Exclusion criteria: 1. Use of dexmedetomidine or clonidine within 12 hours prior to enrollment 2. Extubation for withdrawal of life support 3. Cardiovascular instability manifested by - a. Mean arterial BP less than 5th centile for air despite adequate fluid and vasopressor resuscitation 4. Pateints having 2nd or 3rd degree heart block
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. successful extubation ( defined as - Pateint free from invasive mechanical ventilation for 48 hours following extubation) 2.Post extubation airway obstruction (defined as Wesley croup score more than/equal to 3 anytime in 24 hours following extubationTimepoint: 1. 48 hours following extubation 2. in 24 hours following extubation | — |
Secondary
| Measure | Time frame |
|---|---|
| Peri- extubation agitation ( defined as RASS (Richmond agitation- sedation scale) more than/equal to +1 )Timepoint: from initiation of drug to 24 hours post extubation;Recruitment rate ( defined as proportion of enrolled children amongst total eligible children) Timepoint: ;Protocol adherence ( Time from randomization to initiation of trial drug infusion to extubation Total duration of trial drug infusion Number and duration of trial drug interruptionsTimepoint: ;Accidental extubation ( defined as Candidates who undergo self extubation or accidental extubation before planned extubation)Timepoint: from intiation of drug infusion to extubation;Adverse drug effects( defined as Incidence of bradycardia (defined as heart rate less than 70)/ hypotension (defined as BPless than 5th centile for age)Timepoint: anytime during study period;sedation withdrawal ( defined as WAT score more than/equal to 3 )Timepoint: 48 hours post extubation | — |
Countries
India
Contacts
Public ContactSushen Tandon
Post graduate institute of medical education and research
Outcome results
None listed