Comparison of two devices used during general anesthesia

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/10/046854
• Lead Sponsor: Jerome Kumar R

Brief Summary

COMPARISON OF INTUBATION CHARACTERISTICSOF KING VISION VIDEO LARYNGOSCOPE VS C-MAC VIDEOLARYNGOSCOPE FOR NASOTRACHEALINTUBATION – A RANDOMISED CONTROLLED STUDY

Nasotrachealintubation is essential to provide surgical access in patients who areundergoing oral and maxillofacial surgeries. Nasotracheal intubation is morechallenging than orotracheal intubation due to the difficulty in advancing thetip of the endotracheal tube into the trachea.Video laryngoscopes aid invisualisation of the vocal cords without the need to align the oral, pharyngeal, and tracheal axes hence facilitating intubation. This study will be done tocompare C-MAC D-blade video laryngoscope to non-channelled King Vision videolaryngoscope for nasotracheal intubation. This study will include 86 ASA -1 and ASA-2 patients agedbetween 18 to 59 years undergoing maxillofacial or oral cavity surgeryrequiring nasotracheal intubation. Patients will be divided into 2 groups (43 each) randomly via computer generated sequence. A detailedpreanesthetic evaluation and all the relevant investigations will be done. On arrival in OT,standard ASA monitors will be attached and all patients will bepremedicated using 0.02 mg/kg midazolam, 0.2mg glycopyrrolate, 4mg ondansetron and2mcg/kg fentanyl intravenously. Allthe patients will be preoxygenated with 100% oxygen for 3 minutes. Standard induction will bewith Inj. Propofol 1.5-2mg/kg intravenously and Inj. Atracurium 0.5 mg/kgintravenously for muscle relaxation. Isoflurane will be used as theinhalational agent. Nasotracheal intubation will be performed withappropriately sized RAE(Ring-Adair-Elwin) endotracheal tube by an experienced anaesthesiologist.The primary outcome variable will be total intubation time calculated from the beginning of introduction ofthe RAE endotracheal tube in the nostril till the appearance of the first end‑tidalcarbon dioxide waveform(capnography). This willinclude time required for insertion of the ETT in each of three intubation steps(from nose into oropharynx(T1), from oropharynx into glottic inlet(T2), andfrom glottic inlet to observation of first capnographic trace(T3)). The timetaken will be noted by the Primary investigator using a stopwatch. Thesecondary outcomes will be comparingglottic view as percentageof glottis opening (POGO) score, modified nasal intubation difficulty score (NIDS) and complications related to NTI. Datacollected will be collected and will be tabulated for statisticalanalysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-11
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

American Society of Anesthesiologists physical status(ASA) grade 1 and 2 patients scheduled for elective or emergency maxillofacial or oral cavity surgeries requiring nasotracheal intubation.

Exclusion Criteria

1.Anticipated difficult endotracheal intubation (Mallampati score IV and thyromental distance of ≤6.0cm) 2.Coagulopathy 3.A history of nasal deformity, obstructive sleep apnoea, recurrent epistaxis, nasopharyngeal abnormality or surgery 4.Severe obesity (body mass index [BMI] ≥35kg/m2) 5.Cervical spine instability/pathology or cervical myelopathy 6.Pregnancy 7.Neck mass 8.Gastro oesophageal reflux disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time taken for nasotracheal intubation	T1–Time taken to pass endotracheal tube from nose into oropharynx | T2–Time taken to pass endotracheal tube from oropharynx into glottic inlet | T3–Time taken to pass endotracheal tube from glottic inlet to observation of first capnographic trace

Secondary Outcome Measures

Name	Time	Method
Glottic view as percentage of glottis opening (POGO) score	At the time of laryngoscopy
Modified nasal intubation-difficulty scale (NIDS) rating	At the time of laryngoscopy
Complications in the two groups	At the time of glottic visualization,

Trial Locations

Locations (1)

St Johns Medical college and hospital; 🇮🇳 Bangalore, KARNATAKA, India

St Johns Medical college and hospital

🇮🇳Bangalore, KARNATAKA, India

Jerome Kumar R

Principal investigator

7402055868

jeromekumar.r95@gmail.com