Comparison of two techniques of insertion of the device LMA CTrach on the different maneuvres required to obtain good view of the opening of wind pipe (glottis)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/03/008036
• Date of registration: 08-03-2017
• Prospective Registration: Yes
• Primary sponsor: HARIPRASAD
• Public title: Comparison of two techniques of insertion of the device LMA CTrach on the different maneuvres required to obtain good view of the opening of wind pipe (glottis)
• Scientific title: Comparative evaluation of two techniques of LMA CTrachTM insertion on maneuvers required to obtain optimal laryngeal view
• Date of first enrolment: 20-03-2017
• Target sample size: 50
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14228
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: KRISHNA HM
• Affiliation: Kasturba Medical College, Manipal

• Name: KRISHNA HM
• Affiliation: Kasturba Medical College, Manipal

Key inclusion & exclusion criteria

Inclusion criteria: Patients of either gender aged between 18- 65 years, belonging to American Society of Anesthesiologists (ASA) physical status 1 and 2 with BMI <35 kg/m2 who are scheduled for elective surgical procedures under general anesthesia requiring tracheal intubation.
Exclusion criteria: 1. Mouth opening less than 2.5 cms

2. Patients with risk of regurgitation and pulmonary aspiration (inadequate fasting, pregnancy, morbid obesity, emergency surgeries requiring rapid sequence induction of anesthesia, history suggestive of acid peptic disease)

3. BMI >35 kg/m2

4. Oral, maxillofacial or laryngeal pathology where LMA CTrach• insertion is contraindicated or difficult.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients scheduled for elective surgery under general anesthesia with no comorbidities or mild comorbid illness

Intervention(s)

Intervention1: MODIFIED TECHNIQUE OF INSERTION OF LMA CTRACH: LMA C Trachâ?¢ Airway is inserted after attaching the LMA CTrachâ?¢ viewer or the LMA CTrachâ?¢ viewer is attached to the LMA CTrachâ?¢ Airway soon after its insertion into the oral cavity. Subsequent insertion and maneuvers are done under vision.
Control Intervention1: standard technique of insertion of LMA CTrach as recommended by the manufacturer: LMA CTrachâ?¢ Airway is inserted first and then LMA CTrach viewer is attached only after obtaining adequate ventilation

Primary Outcome(s)

number of manipulations of LMA CTrachâ?¢ Airway required to obtain grade 1 or 2 view of glottisTimepoint: 3 min after administration of vecuronium and before intubation

Secondary Outcome(s)

a. time required to obtain grade 1 or 2 glottic view

b. ease of LMA CTrachâ?¢ insertion

Timepoint: at the time of intubation

Secondary ID(s)

NIL

Source(s) of Monetary Support

MANIPAL UNIVERSITY University building Madhava Nagar Manipal 576104

Ethics review

Status: Approved
Approval date: 13/10/2015
Contact:

INSTITUTIONAL ETHICS COMMITTEE, KASTURBA HOSPITAL, MANIPAL