A clinical study to evaluate the difference between weight based criteria and cricoid-mental distance based criteria for LMA proseal size selection in adult patients undergoing general anesthesia.
- Conditions
- Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,
- Registration Number
- CTRI/2021/12/038728
- Lead Sponsor
- Maulana Azad medical college
- Brief Summary
Supraglottic airway devices (SADs), especially the laryngeal mask airway (LMA), have been extensively adopted as an alternative technique to tracheal intubation or mask ventilation for airway management in short length surgery .
More and more clinicians prefer SADs now than ever before. Recent studies have shown that 50% of patients under general anesthesia in the UK are ventilated with SADs .
Optimal size selection is critical to the safe and effective use of the laryngeal mask airway (LMA). ideally, the optimal LMA should be easy to insert; have an oropharyngeal leak pressure sufficient for positive pressure ventilation; a pharyngeal mucosal pressure less than capillary perfusion pressure; and be positioned such that instruments pass easily into the respiratory tract.
In clinical practice, however, the weight-based criterion is not always applicable, especially for patients in asthenic or stout shape as there is no linear correlation between the upper airway anatomy and body weight due to the individual anatomical variation, as previous studies have demonstrated that the first attempt success rate of LMA insertion based on weight was as low as 77% to 82% .
This study will be prospectively conducted to evaluate the efficacy of cricoid-mental distance-based method versus weight-based method in optimal size selection of Proseal LMA in adults undergoing elective surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- ASA grade I, II -Aged 18 to 60 years -body mass index (BMI) 18.
- 30kg/m2 Expected duration of surgery less than 3 hours.
Patients with high risk of regurgitation or aspiration -Patients with an anticipated difficult airway (including but not limited to a history of difficulty airway, mouth opening <2.5 cm, Mallampati class 4, limited neck extension or cervical spine pathology) -Known respiratory tract pathology -Planned surgery in lateral / prone position -Patients requiring endotracheal intubation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insertion success at first attempt From baseline to time of insertion
- Secondary Outcome Measures
Name Time Method Number of Attempts at Proseal insertion 1st attempt, 2 nd attempt, 3rd attempt. Time to successful insertion the interval beginning with picking up the airway device and ending when a successful airway device placement Ease of insertion graded from 1 to 4 (1 for no resistance, 2 for mild resistance, 3 for moderate resistance, 4 for unable to placement) by the operator who performed the insertion Oropharyngeal leak pressure (OLP)
Trial Locations
- Locations (1)
Lok nayak hospital
🇮🇳Central, DELHI, India
Lok nayak hospital🇮🇳Central, DELHI, IndiaNimith prabhakarPrincipal investigator9591915787nimithp93@gmail.com