To compare intubation through Intubating Laryngeal mask airway and Laryngeal mask airway Protector during airway management.

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2024/01/061261
• Lead Sponsor: IMS AND SUM HOSPITAL

Brief Summary

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|This study will be conducted at our institution over a period of 1.5 years. In this study 80 ASA grade I and II patients between age 18 to 60 years with BMI<35kg/m2 posted for elective surgeries requiring general anesthesia will be included. After taking written informed consent patients will be randomized to two groups (n=80) by computer generated random number table by the anaesthesiologist who is not involved in the procedure. All patients will be thoroughly examined pre-operatively including detailed airway examination and ASA grading. Patients will be kept Nil per oral from night before surgery. Patients will be shifted to the operation room (OR) on the day of surgery. Intravenous (IV) line will be secured with 18G IV cannula. ASA standard monitors *eg*. electrocardiograph (ECG), Noninvasive blood pressure (NIBP) and Arterial oxygen saturation (SpO2) will be attached and all patients will be premeditated with IV glycopyrrolate 0.05mg/kg and IV midazolam 0.03 mg/kg, 10 minutes before induction of anaesthesia.

                 Induction will be done with IV fentanyl 2mcg/kg and IV propofol 2.5 mg/kg. After assessing adequate mask ventilation, muscle relaxation will be facilitated with atracurium 0.5 mg/kg, mask ventilation will be continued for 3 minutes. Then according to allocated group proper size SAD will be selected as per body weight. Both devices will be lubricated using 2% lignocaine jelly and the both SAD fully deflated prior to insertion. ILMAâ„¢ or LMA P will be inserted in neutral neck position. After SAD insertion, confirmation of successful ventilation will be confirmed by continuous square waveform capnography. The numbers of attempts and time required for SAD insertion will be recorded. A failed attempt was defined as removal of the SAD from the mouth before reinsertion. After achieving successful ventilation with SAD, blind ET intubation was attempted using both the devices. If no resistance is felt ET tube will be advanced fully into the SAD.

                  When resistance is felt during ET tube insertion, following maneuvers will be tried in LMA P group: 1) Twisting of the ET tube to align the bevel, up and downward movement of the ET tube gently within the SAD. 2) Application of cricoid pressure (Bhandari G et al. [6]). If resistance is felt during insertion of ET tube in ILMA group, a standardized algorithm [4] will be followed on the basis of the distance at which the resistance is felt and other maneuvers which can be includes: optimizing the airway, rotating the ET tube bevel, adjusting head neck position and adding air to the cuff. Duration of successful ET intubation through SAD is defined as the time elapsed from picking of the ET tube by hand and placing it through SAD until confirmation of square waveform capnography (ETCo2). Airway seal will be checked as: Excellent -No audible leak, Good-Some audible leak present, but ventilation is adequately maintaining ETCO2<40mm/Hg. Poor-Relevant loss of air with insufficient ventilation requiring reposition of devices. Orogastric tube placement will be done using SAD. Easily passing gastric tube through SAD will be confirmed by suctioning of gastric contents.

                In all patients, procedure will be performed by the same experienced anaesthesiologist who has done a minimum 50 successful SAD insertions. Ease of insertion, No. of attempts, time taken for ETT placement through ILMA and LMA P will be recorded. Adequacy of airway seal and oropharyngeal leak pressure will be noted for analysis. Anaesthesia will be maintained with Isoflurane (1 vol%) in oxygen/nitrous oxide (50%/50%) mixture using closed circuit in low flow (1lit). Intermittent bolus of atracurium for muscle relaxation and fentanyl for analgesia will be used. Inta operative monitoring of vitals, Input output charting will be done.

 At the end of surgery, neuromuscular blockade is reversed with a mixture of glycopyrrolate (0.01 mg/kg) and neostigmine (0.05 mg/kg) and extubation will be done after adequate reversal. Patient will be shifted to recovery room for 30mins observation. Post-operative monitoring, anlgesia and PONV prophylaxis will be given. In post-operative period two hours vitals monitored and patients asked about post operative sore throat incidence in 24hrs and noted for analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-15
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Adult patient between the age of 18 – 60 years 2.ASA grade one and two 3.Patient is posted for elective surgery under general anesthesia.

Exclusion Criteria

1.Age more than 60 years 2.ASA grade three and four 3.Patients with maxillofacial trauma and anomalies 4.Patients with restricted neck movements 5.Obesity BMI more than 40kg/m2 6.Limited mouth opening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare ease of intubation, number of attempts and time taken for intubation through Intubating laryngeal mask airway and Laryngeal mask airway protector	Time at insertion of Laryngeal mask airway taken as Time 0 | Time taken for insertion of ET tube through Laryngeal mask airway is noted | Appearence of capnograph is taken as endtime

Secondary Outcome Measures

Name	Time	Method
To compare ease of insertion of SAD, adequacy of airway seal, oropharyngeal leak pressure, ease of gastric tube placement, incidence of post-operative sore throat.	Oropharyngeal leak pressures at time of insertion & 10 mins after insertion

Trial Locations

Locations (1)

IMS AND SUM HOSPITAL; 🇮🇳 Khordha, ORISSA, India

IMS AND SUM HOSPITAL

🇮🇳Khordha, ORISSA, India

DR PEDIREDDY SOBHA RANI

Principal investigator

8790831687

pedireddyshoba78@gmail.com