CTRI

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CTRI Number

CTRI/2025/08/093050 [Registered on: 14/08/2025] Trial Registered Prospectively

Last Modified On:

13/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Medical Device
Surgical/Anesthesia

Study Design

Other

Public Title of Study

Studying how different head and neck positions affect the fit of a breathing mask used during surgery

Scientific Title of Study

Influence of different head and neck positions on oropharyngeal leak pressure with laryngeal mask airway protector in elective surgeries

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Praveen kumar S
Designation	Junior resident
Affiliation	Government Medical College and Hospital,Chandigarh
Address	Department of Anaesthesia and Intensive Care,Block D,Level 5,GMCH,Sector 32-B,Chandigarh CHANDIGARH 160030 India Chandigarh CHANDIGARH 160030 India
Phone	8610745088
Fax
Email	praveenlycan88@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Deepak Thapa
Designation	Professor
Affiliation	Government Medical College and Hospital,Chandigarh
Address	Department of Anaesthesia and Intensive Care,Block D,Level 5,GMCH,Sector 32-B,Chandigarh CHANDIGARH 160030 India Chandigarh CHANDIGARH 160030 India
Phone	9646121524
Fax
Email	dpkthapa@gmail.com

Details of Contact Person
Public Query

Name	Dr Vanita Ahuja
Designation	Professor
Affiliation	Government Medical College and Hospital,Chandigarh
Address	Department of Anaesthesia and Intensive Care,Block D,Level 5,GMCH,Sector 32-B,Chandigarh CHANDIGARH 160030 India Chandigarh CHANDIGARH 160030 India
Phone	9646121649
Fax
Email	vanitaanupam@gmail.com

Source of Monetary or Material Support

Department of Anaesthesia and Intensive Care,Block D,Level 5,GMCH,Sector 32-B,Chandigarh CHANDIGARH 160030 India

Primary Sponsor

Name	Government Medical College and Hospital
Address	Department of Anaesthesia and Intensive Care,Block D,Level 5,GMCH,Sector 32-B,Chandigarh CHANDIGARH 160030 India
Type of Sponsor	Government medical college

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 Praveen Kumar S	Government Medical College and Hospital	Department of Anaesthesia and Intensive Care,Block D,Level 5,GMCH,Sector 32-B,Chandigarh CHANDIGARH 160030 India Chandigarh CHANDIGARH	8610745088 praveenlycan88@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Commitee,GMCH,Chandigarh	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL
Intervention	Supraglottic airway device	Supraglottic airway device(LMA PROTECTOR) will be inserted after induction and neuromuscular blockade to secure the airway.The Oropharyngeal Leak Pressure in cm of water is measured after 5minutes in each head position (neutral,flexion,extension,right lateral and left lateral position) of head and neck after establishing the airway.Once the surgery is over,the patient will be reversd and the supraglottic airway device will be removed.Patient will be monitored in the postoperative ward for 30 minutes

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1.Patients with American society of anaesthesiologist physical status grade 1 and 2 2.age between 18-70 3.patients undergoing elective surgeries requiring controlled ventilation under general anaesthesia.

ExclusionCriteria

Details

1. Patients with anticipated difficult airway Airway Difficulty Score 2. Morbid obesity
3. Pregnant women
4. Major maxilla-facial trauma or cervical spine pathology
5. Severe cardiorespiratory, cerebrovascular, renal, hepatic or musculoskeletal diseases
6. Severe coagulopathy or history of anticoagulant use
7. Patients at increased risk of pulmonary aspiration such as gastroesophageal reflux disease, peptic ulcer disease, full stomach 8. Surgery in prone position

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Comparing the difference in oropharyngeal leak pressure with changes in head and neck positions using the LMA Protector airway device	After induction and 5minutes after neutral head position,5minutes after flexion head position,5minutes after extension head position,5minutes after right lateral position and 5minutes after left lateral head position.

Secondary Outcome

Outcome

TimePoints

1.To study the insertion time of LMA Protector
2.To study the number of attempt required for insertion
3.To study the ease of insertion of the device
4.To study hemodynamic variations in different head & neck positions
5.To study fiberoptic assessment of glottic view through the device.
6.To study post-operative complications such as sore throat, stridor or hoarseness, dental
trauma, any other relevant complications.

1.After insertion of LMA device
2.After insertion of LMA device
3.After indertion of LMA device
4.5minutes after each head position flexion,extension,neutral,right lateral,left lateral head position
5.30 minutes after insertion of LMA device
6.Immediately after removal of LMA tube to 48 hours after removal to tube

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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 4

Date of First Enrollment (India)

15/09/2025

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="1"
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

Airway management has evolved considerably over the past decade, primarily due to advancements in Supraglottic Airway Devices These devices provide a significant alternative in general anesthesia for situations where tracheal intubation poses challenges, facilitating ventilation and oxygenation. It is particularly beneficial in emergency situations and for patients with anatomically complex airways.SADs are generally categorized into first and second generation devices. First generation equipments include the use of a basic airway pipes such as the laryngeal mask airway without features aimed at minimizing aspiration. Second generation, like the ProSeal LMA, I-gel and LMA Protector contains more newer features like gastric drainage port and epiglottis blockers which both improve safety and efficiency. The effectiveness of supraglottic airway devices particularly their ability to maintain a proper seal can depend on head movements. Flexing neck decreases anteroposterior diameter of pharynx by relieving anterior pharyngeal muscle tension, while extending the neck increases this diameter.Most supraglottic airway devices are designed to be inserted gently into oropharynx to create a reliable seal, ensuring consistent ventilation. Ongoing clinical research evaluating the LMA Protector have indicated that it allows for straightforward insertion and achieves superior oropharyngeal leak pressures relative to other routinely utilised devices. We hypothesize that laryngeal mask airway protector achieves superior OLP in flexion head position.

AIM

To observe the Influence of different head and neck positions on oropharyngeal leak pressure with Laryngeal Mask Airway Protector airway in elective surgeries

PRIMARY OBJECTIVE:

Comparing the difference in oropharyngeal leak pressure with changes in head and neck positions using the LMA Protector airway device

SECONDARY OBJECTIVE:

To study the insertion time of LMA Protector

To study the number of attempt required for insertion

To study the ease of insertion of the deviceTo study hemodynamic variations in different head and neck positions

To study fiberoptic assessment of glottic view through the device. To study post-operative complications such as sore throat, stridor or hoarseness, dental

trauma, any other relevant complications.

METHODOLOGY

The study protocol outlines thorough pre anaesthesia workup including physical examinations and various test and assessment of dufficult airway.patients will be advised fasting and will be premedicated accordingly.During anaesthesia standard procedures will be followed,including preoxygenation,induction with propofol,and neuromuscular blockade.After insertion of LMA,monitoring parameters are measured. mode. Hemodynamic parameters [HR (heart rate), ECG, NIBP,SpO2 and End Tidal Carbon dioxide will be monitored and recorded with every head positions.After the end of surgery and reversal from anaesthetic agents, the study device will be removed and the incidence of blood stain on the device will be recorded.

Following observations will be recorded in all the patients:

1. OLP in cm of water, in neutral, flexion, extension, right lateral and left lateral position of head and neck

2. Time taken for SAD insertion

3. Ease of insertion of SAD. The ease of insertion of device will be graded.

4. Number of attempts for successful SAD insertion.

5. Fibreoptic grading of the laryngeal view through the study device.

6. Any adverse events during the procedure like oxygen desaturation, soft tissue or dentaltrauma, blood stain on device.

7. Degree of postoperative sore throat

8. Intraoperative hemodynamic parameters HR, NIBP,oxygen saturation end-tidal carbondioxide level preoperatively, before and after insertion, in all head positions.