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Clinical Trials/CTRI/2020/12/029692
CTRI/2020/12/029692CompletedNot Applicable

Comparison of Cuff Inflation and Conventional Technique for Nasotracheal Intubation using C-MAC Video Laryngoscope. A Prospective Randomised Controlled Trial.

All India Institute of Medical Sciences1 site in 1 country106 target enrollmentStarted: January 14, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
106
Locations
1
Primary Endpoint
Primary outcome of our study is Time taken for ETT placement(defined as time taken after the confirmation of tip of endotracheal tube in nasopharynx by C-MAC video laryngoscope to the appearance of three successive end tidal CO2 waveforms.

Study Overview

Brief Summary

Surgical procedure involving head and neck region, intraoral, maxillofacial and dental procedures usually mandate nasotracheal intubation (NTI). Advantage of NTI is that it better isolates surgical field from artificial airway so that the endotracheal tube is less vulnerable to kinking, damage due to surgical instrumentations. In addition, postoperatively nasal tube is better tolerated than the oral route and require less sedation. Nasotracheal intubation involve passing of tube through one of the nostril till the tube reaches nasopharynx and then with help of video or macintosh laryngoscope it is guided through vocal cord by various manoeuvres like burp, neck movement, tube rotation, use of bougie or by using Magill’s forceps. These manoeuvres lead to longer intubation time, trauma, bleeding of nasopharyngeal wall and hemodynamic stress response while negotiating the tube into trachea. 

Cuff inflation technique (wherein the cuff of ET tube is inflated with air) in which after inflation of the cuff  the endotracheal tube is lifted away from the posterior pharyngeal wall and gets aligned with the laryngeal inlet  and  tip of the tracheal tube is engaged with  the glottis opening. Once the tip of tube passes through the glottis, cuff is deflated and tube is further advanced.

Cuff inflation technique has not been compared with conventional technique yet. Hence, we plan to compare these two techniques of nasal intubation. We hypothesize that cuff inflation technique will have faster intubation time and less manipulation in comparison to conventional nasal intubation technique.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Patient scheduled for elective surgery requiring nasal intubation 2 American Society of Anaesthesiologists (ASA) physical status 1-2.

Exclusion Criteria

  • 1 Patient refusal 2 known difficult Airway 3 Patient with mouth opening <2.5cm 4 Patient difficult to mask ventilate 5 History of larynx surgery or larynx radiotherapy 6 Anticipated esophago-tracheal reflux 7 mallampati view 3 or 4 8 Frequent episodes of epistaxis or bleeding tendency 9 patients with significant systemic disease 10 Patient having Contraindications for NTI.

Outcomes

Primary Outcomes

Primary outcome of our study is Time taken for ETT placement(defined as time taken after the confirmation of tip of endotracheal tube in nasopharynx by C-MAC video laryngoscope to the appearance of three successive end tidal CO2 waveforms.

Time Frame: Primary outcome of our study is Time taken for ETT placement(defined as time taken after the confirmation of tip of endotracheal tube in nasopharynx by C-MAC video laryngoscope to the appearance of three successive end tidal CO2 waveforms by the end of 1 minute, beyond one minute attempt is considered a failure.

Secondary Outcomes

  • 1 Type and number of manoeuvres (M1-M4) used(2 Hemodynamic response to intubation)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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