Efficacy of High Flow Nasal Cannula Versus Non- Rebreathing Mask During Endotracheal Intubation In critically ill Children : A Randomised Clinical Trial
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Ganga ram institute for postgraduate medical education and research
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Lowest saturation
Overview
Brief Summary
This is a randomized clinical trial will be conducted in children 1 month to 18 years of age undergoing intubation in a pediatric intensive care .Ninety participants will be randomized to either high flow nasal cannula(HFNC) or non - rebreathing mask(NRM) for preoxygenation prior to intubation. Those randomized to the HFNC will be given heated humidified high flow nasal cannula at a rate of 2l/kg/min ( above 12 kg , add 0.5 l/kg/min with maximum flow of 50l/min ) with 100% fio2 for 4 minutes. In the NRM group, preoxygenation will be done with 15l/min flow and patients will be intubated. The aim is to compare the lowest saturation measured during endotracheal intubation from the insertion of laryngoscope to ventilator connection between patients with HFNC and NRM .These findings may contribute to the better understanding of the newer methods of pre- oxygenation .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Month(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All male and female patients from 1 month to 18 years requiring elective endotracheal intubation.
Exclusion Criteria
- •Endotracheal intubation for cardiac arrest.
- •Emergent endotracheal intubation is indicated for conditions such as bradycardia, ventricular fibrillation, and heart block.
- •Nasopharyngeal obstruction with midline facial deformities of the jaw, nose, and larynx.
- •Children with chromosomal anomalies.
- •Children requiring reintubation.
- •Children unable to achieve saturation greater than 90% after preoxygenation for 4 minutes.
Outcomes
Primary Outcomes
Lowest saturation
Time Frame: Lowest oxygen saturation from the start of laryngoscopy insertion until connection to the ventilator.
Secondary Outcomes
- Difficult intubation(Two failed attempts at direct laryngoscopy & one attempt will be counted as 30 seconds.)
- Time required for intubation(From the insertion of the laryngoscope to the connection to the ventilator.)
- Organ failure(During the first five days in the PICU, the assessment will be conducted using the PELOD score.)
- Complications During Endotracheal Intubation(During endotracheal intubation & the subsequent hour.)
- Time on ventilator(The duration will be calculated in days, starting from the day of intubation on the mechanical ventilator to the day of extubation.)
- Length of hospital stay(From the commencement of successful intubation to the point of hospital discharge.)
- Ventilator associated pneumonia(Achieving a score greater than 6 on the CPIS scale will result in the absolute number of patients being considered.)
Investigators
Dr Anil sachdev
Sir gangaram hospital , rajinder nagar , new delhi