A study to compare two methods of inserting tube in the windpipe (oro-tracheal intubation) in children requiring ventilator support

Not yet recruiting

Conditions: Neoplasms,

Registration Number: CTRI/2023/09/057898

Lead Sponsor: Tata Memorial Hospital

Brief Summary: The airway anatomy of the childrenis distinctive as compared with adults. The laryngoscopy and intubation inchildren are difficult because of restricted opening of the mouth,comparatively larger tongue and more cephalad larynx; also, the consumption ofoxygen is much higher in children as compared to the adults. Hence, limitedperiod is available for the intubation in children(1).The presence ofcongenital orofacial clefts distort the upper airway anatomy and associationwith wider palatal clefts, bilateral cleft lips, major nasal deformity, micrognathiaand receding mandible also increases the intubation difficulty.(2)

Particularly in cancer patient with pneumonia,radiation exposure, anterior mediastinal mass, orofacial tumors, bleedingtendency, distorted airway will further reduce the time window and increasedifficulty in tracheal intubation.

In VL, the scope incorporatesan integrated camera and display monitor, which is used for indirectlaryngoscopy to view the airway structures Since the view is obtained â€œaround thecornerâ€ the glottis is visualized better by the VL. A lesser quantity of forceis required at the base of the tongue during VL. Hence, the chances of localtissue injury and response to stress are reduced. Even though there is limited evidencethat the success of endotracheal intubation (ETI) is increased by VL, VL is nowmore.(3)

Since there are no comparative ICU studiesavailable for pediatric population, we decided to conduct this study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Children age between 1 to 12 years admitted in ICU who need oro-tracheal intubation.

Exclusion Criteria

a)Age < 1 year and > 12 years b)Unstable C-spine c)Cardiac arrest scenario d)Children on palliative care intent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First attempt success rate of orotracheal intubation in critically ill children with cancer.	Immediately post intubation

Secondary Outcome Measures

Name	Time	Method
1.Time required for orotracheal intubation	2.Incidence of mild desaturation (92%)

Trial Locations

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Atul Kulkarni
Principal investigator
9869077526
kaivalyaak@yahoo.co.in