CTRI

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CTRI Number

CTRI/2026/02/104263 [Registered on: 18/02/2026] Trial Registered Prospectively

Last Modified On:

17/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A Study to understand the ease and effect of cuff inflation of the tracheal tube when passed through nose to secure the airway

Scientific Title of Study

Evaluation of the effect of endotracheal tube cuff inflation on the ease of nasotracheal intubation under video laryngoscopy. A prospective randomised study.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Mohammed Ali Khan
Designation	Junior resident
Affiliation	NIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA, HYDERABAD
Address	Room n0. 7, 3rd floorn NIMS Specialty Block, NIMS, PUNJAGUTTA, HYDERABAD , TELANGANA Hyderabad TELANGANA 500082 India
Phone	8919621988
Fax
Email	mohammedalikhan3799@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Nirmala Jonnavithula
Designation	Professor
Affiliation	Nizams institute of medical sciences
Address	Room no 1, Specialty block OT, Department of Anesthesia, #rd floor specialty block Punjagutta, Hyderabad- 500082, Telangana Hyderabad TELANGANA 500082 India
Phone	9849422749
Fax
Email	njonnavithula@gmail.com

Details of Contact Person
Public Query

Name	Dr Mohammed Ali Khan
Designation	Junior resident
Affiliation	Nizams institute of medical sciences
Address	Room n0. 7, 3rd floorn NIMS Specialty Block, NIMS, PUNJAGUTTA, HYDERABAD , TELANGANA Punjagutta, Hyderabad- 500082, Telangana Hyderabad TELANGANA 500082 India
Phone	8919621988
Fax
Email	mohammedalikhan3799@gmail.com

Source of Monetary or Material Support

department of anesthesia, Nizams institute of medical sciences, punjagutta, hyderabad 500082, india

Primary Sponsor

Name	Dr Mohammed Ali Khan
Address	Room no 7, 3rd floor, Nims Specialty block, Nizams institute of medical sciences, Punjagutta, hyderabad 500082, telangana
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Mohammed Ali Khan	NIMS Specialty Block OT	3rd floor specialty block,department of anesthesia Nizams institute of medical sciences, Punjagutta, Hyderabad 500082 Hyderabad TELANGANA	8919621988 mohammedalikhan3799@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
NIMS INSTITUTIONAL COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	healthy human volunteers undergoing surgeries that require nasotracheal intubation

Intervention / Comparator Agent

Type	Name	Details
Intervention	intubation with cuff inflation technique	after the endotracheal cuff is visualised in the oropharynx, cuff is inflated giving the tube a lift and bringing it in alignment with vocal cords, deflate the cuff and advance through the glottis between the vocal cords
Comparator Agent	intubation without cuff inflation technique	once the endotracheal tube is visualised, it is advanced to see if it passes through the vocal cords, if it doesnt pass, rescue methods like magills forceps or bougie will be deployed.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Age between 18–65 years 2. American society of anesthesia classification physical status I and II 3. Body mass index BMI less than 30 kg/m² 4. Mallampati Grade I or II, patients withouit a difficult airway 5. Patients who provide written informed consent

ExclusionCriteria

Details

1. patient refusal
2. Syndromic patients or those with congenital craniofacial or airway abnormalities
3. History of previous head and neck surgery
4. Anticipated difficult airway like mouth opening less than 1.5 cm, restricted neck movements.
5. Coagulopathy or bleeding disorders
Known allergy to local anesthetics

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
To compare the total intubation time (TIT) between the cuff inflation technique and the non cuff inflated technique under video laryngoscopy as a measure of procedural ease.	T1- the total time taken to pass te he endotracheal tube from nose till it is visualised in the oropharynx t2- time taken to pass the tube from the oropharynx to the glottis between the vocal cords

Secondary Outcome

Outcome

TimePoints

1. To compare the success rate and number of attempts required for nasotracheal intubation between both groups.
2. To objectively assess and compare the intubation difficulty using the Intubation Difficulty Scale (IDS).
3. To evaluate the need for adjuncts or alternative techniques such as Magill’s forceps or bougie.
4. To assess the incidence of intraoperative trauma, including nasal bleeding, mucosal injury, or cuff rupture.
5. To compare post-extubation complications, such as sore throat, hoarseness, and pain on swallowing, between both groups.

Target Sample Size

Total Sample Size="77"
Sample Size from India="77"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2/ Phase 3

Date of First Enrollment (India)

02/03/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Nasal intubation is a routine mode of intubation for patients undergoing oral and maxillofacial surgeries. The conventional method of nasal intubation involves the use of Magill’s forceps under direct laryngoscopy to advance the tube into glottis which has its own disadvantages including a longer duration, trauma to the glottis including vocal cords and soft tissues and the damage to the endotracheal tube as well. To avoid the mentioned implications, we can perform the intubations under video laryngoscope using the cuff inflation technique where once the tube is into the glottis via the nostrils, visualized under a video scope the ET cuff is inflated with air and this caused a lift to the tube bring it into the alignment with the vocal cords and the tube is passed further, deflated once the tip reaches the vocal cords and inflated once again after it crosses the vocal cords. this technique saves time and prevents trauma to the soft tissue and the tube.