A clinical trial to compare lower vs higher dose of dexamethasone to prevent post extubation airway obstruction in childre
- Conditions
- Health Condition 1: null- PEDIATRIC INTENSIVE CARE PATIENTS UNDERGOING EXTUBATION FROM VENTILATIONHealth Condition 2: J152- Pneumonia due to staphylococcus
- Registration Number
- CTRI/2017/08/009273
- Lead Sponsor
- PGIMER CHANDIGARH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Age >3 months to <12 years.
2.Intubated for >=48 hrs.
3.Undergoing their first elective extubation in the PICU.
Exclusion Criteria
1.Upper airway obstruction due to infection, trauma, burns, surgery as indication for intubation.
2.Corticosteroid therapy within previous 7 days.
3.Chronic treatment with NSAIDs or corticosteroids.
4.Patients likely to have poor airway reflexes as those with best motor and eye response of Glassgow Coma Score <8 (at the time of time of screening for enrollment), cases of GB Syndrome, Tetanus and similar neuromuscular disease.
5.A history of previous tracheal intubation or tracheostomy.
6.Congenital upper airway obstruction e.g., laryngotracheomalacia etc.
7.Chronic lung disease e.g., cystic fibrosis, bronchopulmonary dysplasia.
8.A medical condition that contraindicate the use of corticosteroids.
9.Presence of gastrointestinal bleeding, hypertension ( >95th centile) and hyperglycemia at the time of screening.
10.Patient got self-extubated or extubation was cancelled for any reason prior to completion of initial 5 doses of the intervention drug.
11.The clinical status deteriorated prior to completion of initial 5 doses of the intervention drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eed for adrenaline nebulization any time during first 24 hours after extubationTimepoint: 24 hours after first extubation
- Secondary Outcome Measures
Name Time Method 1.Maximal WCS recorded during the time between 20min -24hours. <br/ ><br>2.Need for re-intubation during 24 hours of extubation. <br/ ><br>3.PICU stay after the first extubation under consideration. <br/ ><br>4.Incidence of adverse events related to dexamethasone use.Timepoint: Upto 48 hours