Comparing the efficacy of two different types of airway devices in children undergoing surgery.

Recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2024/01/061573

Lead Sponsor: Sanjay Gandhi Postgraduate Institute Of Medical Sciences

Brief Summary: Airway management is one of the most essential and life-saving skills for an anaesthesiologist. There are several methods for airway management, but laryngoscopy and endotracheal intubation are considered the gold standard for securing the airway, however, it is difficult to learn and retain these skills. To overcome this problem classic Laryngeal mask airway (LMA classic) was introduced in 1983 by Archie Brain.LMA classic had limitations like a moderate pharyngeal seal and risk of regurgitation of gastric contents and aspiration with positive pressure ventilation. To overcome these limitations, a separate gastric channel was incorporated into the design of the classic and further several modifications led to the development of LMA ProSealÂ®.SADs have a lower risk of respiratory complications like throat pain, cough and dysphagia. Initially, LMA ProSealÂ® was introduced in adult sizes in the year 2001, later on Paediatric sizes were introduced in 2004. A meta-analysis conducted in 2017 found LMA ProSealÂ® to be the best supraglottic airway device for children as it has high oropharyngeal leak pressure and a low risk of insertion. The LMA BlockBusterÂ® is a second-generation supraglottic airway device introduced in early 2012. Successful studies with LMA BlockBusterÂ® have been carried out for controlled ventilation in adults with high oropharyngeal leak pressure (OLP). However, there is limited literature regarding the use of LMA BlockBusterÂ® in paediatric patients. In this study, we aim to compare the performance characteristics of LMA ProSealÂ® and LMA BlockBusterÂ® in children undergoing surgical procedures under general Anaesthesia. Seventy children aged between 1 year to 12â€‰years with normal airways will be randomized into two groups using a computer-generated random number table. Inclusion Criteria: ASA I and II patients, Both male and female patients between 1-12 years, Elective procedures under General Anaesthesia. Exclusion Criteria: Parents/Patient attendant not giving consent, Weight less than 5 kg, Patients with BMI > 30 kg/m2, History of recent upper respiratory tract infection, Inadequate fasting, Patients with contraindications to SAD (restricted mouth opening, upper airway obstruction etc.), Patients with abnormal/distorted anatomy of the upper airway, Head, neck and oral surgery, Patients with increased risk of aspiration (GERD, Hiatus Hernia etc.), Emergency surgeries. After taking the patient to the operation theatre and administration of general anaesthesia, an appropriate size supraglottic airway will be inserted according to the age groups. Success and ease of supraglottic airway insertion, time of supraglottic airway insertion, oropharyngeal leak pressure, leak fraction, success and ease of gastric tube insertion, time of gastric tube insertion, and adverse effects were noted. The glottic view will be graded by fibreoptic scoring. Following surgery, residual neuromuscular paralysis will be reversed with neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg BW. The device will be removed when the patient will be awake and responsive. The patient will be inspected for any complications related to LMA insertion like -injury to lips, tongue, teeth and oropharyngeal tissues. On removal of the device presence of blood stain, will be noted. Cough, sore throat, change of voice, and dysphagia will be recorded (at 1h, 6h, 12h, and 24h).

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 70

Inclusion Criteria

1)ASA I and II patients.
2)Both male and female patients between 1-12 years of age.
3)Elective procedures under General Anaesthesia.

Exclusion Criteria

1.Parents/Patients attendant not giving consent.
2.Weight less than 5 kg.
3.Patients with BMI > 30 kg/m2.
4.History of recent upper respiratory tract infection.
5.Inadequate fasting.
6.Patients with contraindications to SAD (restricted mouth opening, upper airway obstruction etc.).
7.Patients with abnormal/distorted anatomy of the upper airway.
8.Head, neck and oral surgery.
9.Patients with increased risk of aspiration (GERD, Hiatus Hernia etc.).
10.Emergency surgeries.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oropharyngeal Leak Pressure will be measured as the primary outcome.	Immediately after supraglottic airway device insertion.

Secondary Outcome Measures

Name	Time	Method
First-attempt and overall success rate of LMA insertion	2. Device insertion time

Trial Locations

Locations (1): Sanjay Gandhi Postgraduate Institute of Medical Sciences
🇮🇳
Lucknow, UTTAR PRADESH, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Ashish Kumar Kannaujia
Principal investigator
8765974042
ashishkannaujia77@gmail.com