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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  
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 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  
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 
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.

 
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