Ultrasound of airway device to assess its correct position in children undergoing general anaethesia.
- Conditions
- Measurement and Monitoring,
- Registration Number
- CTRI/2023/05/052419
- Lead Sponsor
- Dr Purva Dipak Bhide
- Brief Summary
In children, I-Gel is the most common Supraglottic Airway Device (SGAD) used to provide lung ventilation during general anaesthesia for minor superficial surgeries.
Clinically, the position of I-Gel is assessed by symmetrical bilateral chest expansion, auscultation of the chest, absence of audible oropharyngeal leakage, square wave capnogram and the seal pressure the pressure beyond which leak starts occurring at a constant flow However, these methods do not provide information regarding the site of the leakage and hence appropriate correctional manoeuvres may not be possible.
Although fibreoptic laryngoscopy (FOL) is considered the gold standard validation tool for the direct visualization of the glottis, it gives idea about only anatomical position and does not provide functional assessment.
Ultrasound imaging is a non-invasive, fast, easy, replicable, and portable technology which can provide not only anatomical but also functional assessment of the airway.
Our study aims to assess the utility of USG to detect the optimal position of the I-Gel, the cause of malpositioning and comparison of its performance with the FOL examination, seal pressure values and clinical parameters in non paralysed patients.
After the I-Gel placement, its position will be confirmed by seal pressure values, USG examination of the neck and fibreoptic laryngoscopy.
If there is malposition of the I-Gel, appropriate correcting manoeuvres will be performed and the seal pressure assessment, USG examination of the neck and fibreoptic laryngoscopy will be repeated.
The objectives of the study are as follow:
1. To assess utility of ultrasonography in comparison to clinical parameters in confirming optimal position of I-Gel in children.
2. To assess utility of ultrasonography in comparison to Fibreoptic laryngeal view (FOL) in confirming optimal position of I-Gel in children.
3. To assess utility of ultrasonography in comparison to seal pressure in confirming optimal position of I-Gel in children.
4. To assess utility of ultrasonography in finding out the cause of suboptimal position and repositioning of I-Gel in children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 102
Children undergoing general anaesthesia using I-GEL as a supraglottic airway device.
- Wherever USG assessment of the neck is not possible e.g. 1.
- Children with anterior neck mass.
- Children with burns of anterior surface of neck.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of Ultrasonography as a utility in confirming optimal position of I-Gel in children. After induction of anaesthesia.
- Secondary Outcome Measures
Name Time Method Assessment of ultrasonography as utility in identifying the cause of malposition of I-Gel (asymmetrical, caudad, cephalad, intraglottic placement, or epiglottis downfolding) and thereby guiding in correcting malposition of I-Gel placement. After induction of anaesthesia and after repositioning of I-gel.
Trial Locations
- Locations (1)
Lokmanya Tilak Municipal Medical College
🇮🇳Mumbai, MAHARASHTRA, India
Lokmanya Tilak Municipal Medical College🇮🇳Mumbai, MAHARASHTRA, IndiaDr Purva Dipak BhidePrincipal investigator8208044598purvabhide1994@gmail.com