| CTRI Number |
CTRI/2025/07/091135 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of straight head position versus head rotation on air entry into stomach during facemask assisted breathing in adults undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparison of neutral position versus Lateral Head Rotation on Gastric Insufflation during Facemask Ventilation in Adults undergoing General Anaesthesia: A Randomized
Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suryanarayanan S |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantri Nagar, Gorimedu
Pondicherry PONDICHERRY 605006 India |
| Phone |
08754924600 |
| Fax |
|
| Email |
surya19692@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Suryanarayanan S |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanvantri Nagar, Gorimedu
Pondicherry PONDICHERRY 605006 India |
| Phone |
08754924600 |
| Fax |
|
| Email |
surya19692@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Suryanarayanan S |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanvantri Nagar, Gorimedu
Pondicherry PONDICHERRY 605006 India |
| Phone |
08754924600 |
| Fax |
|
| Email |
surya19692@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Hospital, Gorimedu, Pondicherry, 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Gorimedu, Pondicherry, 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suryanarayanan S |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Anaesthesiology and Critical Care, JIPMER, Gorimedu, Pondicherry - 605006 Pondicherry PONDICHERRY |
8754924600
surya19692@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lateral Head rotation |
Baseline antral cross sectional area will be measured using ultrasonography in the supine position. After the induction of general anaesthesia, the patients head will be rotated axially to either the left or right side by 45 degrees during face mask ventilation until airway is secured with an endotracheal tube.
Incidence of gastric insufflation during facemask ventilation will be noted and gastric antral cross-sectional area will be measured after the intervention using ultrasound. |
| Comparator Agent |
Neutral Head position |
Baseline antral cross sectional area will be measured using ultrasonography in the supine position. After the induction of general anaesthesia, the patients head will be kept in the standard neutral position during face mask ventilation until airway is secured with an endotracheal tube.
Incidence of gastric insufflation during facemask ventilation will be noted and gastric antral cross-sectional area will be measured after the intervention using ultrasound. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective surgeries under general anaesthesia requiring endotracheal intubation
2. American Society of Anesthesiologists physical status I and II
3. Body mass index of 18–30 kilogram per square metre. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Anticipated difficult airway
3. High risk for aspiration
4. Pregnant women
5. Oropharyngeal or facial pathology
6. Known respiratory disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of gastric insufflation as evidenced by comet-tail artefacts using ultrasonography during facemask ventilation between the lateral head rotation and the neutral head position. |
During the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the gastric antral cross-sectional area using ultrasonography after facemask ventilation |
Baseline & after the intervention |
| To compare the peak inspiratory pressures for achieving expiratory tidal volume of 8 ml/kg of predicted body weight |
During the intervention |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
14/08/2025 |
| 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="0" 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
|
Facemask ventilation is a fundamental airway management skill that is vital for ensuring adequate oxygenation and ventilation during resuscitation and the induction of general anaesthesia. Facemask ventilation in an obstructed airway requires peak inspiratory pressures between 25 to 30 cm H2O, which may cause gastric insufflation in 40-60 percentage of population. The resulting rise in intra-gastric pressure can result in complications such as regurgitation of gastric contents leading to aspiration pneumonia, postoperative nausea and vomiting, reduced lung compliance and cardiac output. Studies have shown that 45 degree lateral head rotation can be an effective alternative to the neutral position for enhancing mask ventilation when airway obstruction occurs. Lateral head rotation significantly enlarges the upper airway diameter in the neck, increases the cross-sectional area in the retroglossal region, and shifts soft tissue away from the submandibular space, thereby reducing upper airway obstruction. While previous studies have examined the effects of various levels of peak inspiratory pressure on gastric insufflation in the neutral head position, the influence of lateral head rotation on gastric insufflation has not yet been investigated. With this knowledge, we expect lateral head rotation to effectively relieve airway obstruction, reduce peak inspiratory pressures, and minimize gastric insufflation during facemask ventilation in apneic adults. |