Oropharyngeal leak pressure of LMA Protector Vs LMA Proseal in different head and neck positions

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/04/032611

Lead Sponsor: Maulana Azad Medical College and associated Lok Nayak Hospital

Brief Summary: The oropharyngeal leak pressure is marker of efficacy of supraglottic devices. As the pharyngeal anatomy changes accroding to different head and neck position, the performance of supraglottic device may be affected.Proseal LMA is considered criterion standard supraglottic device and its superiority has been established in terms of better oropharyngeal leak pressure over LMA Classic, LMA Supreme and i gel.Previous studies have suggested that it can be utilized regardless of head and neck position.

We will be comparing oropharyngeal leak pressures of LMA Protector, a new supraglottic device and LMA Proseal in 70 patients scheduled for elective surgeries. Standrad protocol for preanaesthetic surgery will be followed and consent for participation in trial will be taken.On the day of surgery , general anaesthesia will be induced in standard manner. Based on computer generated random table patients will be allocated to one of the two groups; in one group LMA protector will be used and in another LMA Proseal . The primary outcome of study will be comparison of oropharyngeal leak pressure of two devices in neutral, flexion, extension and lateral rotation of head and neck. Number of attempts for sucessful insertion, ease of insertion,laryngeal view on fibreoptic bronchoscopy, ease of insertion of nasogastric tube,, presence of blood on cuff of device after extubation and postoperative sore throat.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Age>18 years ASA physical status I & II Anticipated duration of surgeryâ‰¤ 2 hours.

Exclusion Criteria

Known or predicted difficult airway -Patients with pre-existing cervical spine pathology (neck pain or tenderness in cervical spines or associated paraesthesia in upper limbs) -BMI > 35kg/m2 -Thorax, major upper abdomen, Head & neck surgeries -Surgeries requiring lateral or prone positioning -Patient at risk of aspiration such as pregnant patients, those with inadequate fasting, hiatal hernia, gastric outlet obstruction -Mouth opening less than 3 centimetres.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oropharyngeal leak pressures of LMA protector and PLMA in different head and neck positions	after insertion of devices

Secondary Outcome Measures

Name	Time	Method
number of attempts for successful insertion of devices	after insertion of devices
time taken for successful insertion of devices	during insertion of devices
ease of placement of devices	after placement of devices
ease of placement of nasogastric tubes through devices	after placement of devices
presence of blood on the cuff of devices	when the device is taken out from patients during extubation
postoperative sore throat	1, 2 and 24 hours after surgery

Trial Locations

Locations (1): Lok Nayak Hospital and associated trauma centre
🇮🇳
Central, DELHI, India
Lok Nayak Hospital and associated trauma centre
🇮🇳Central, DELHI, India
Sukhyanti Kerai
Principal investigator
9968527122
drsukhi25@gmail.com