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CTRI Number  CTRI/2025/09/094615 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Ultrasound Assessment of the Airway in Pregnant Women With Pre-eclampsia and Those With Normal Blood Pressure 
Scientific Title of Study   COMPARISON OF ULTRASOUND BASED AIRWAY ASSESSMENT PARAMETERS IN PRE-ECLMAPTIC AND NORMOTENSIVE PARTURIENTS 
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 A Arbika 
Designation  PG resident 
Affiliation  VMMC and Safdarjung Hospital  
Address  Department of Anaesthesia and Intensive Care, ground floor, Main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi

South West
DELHI
110029
India 
Phone  9489574028  
Fax    
Email  arbika21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charu Bamba 
Designation  Professor and Consultant  
Affiliation  VMMC and Safdarjung Hospital  
Address  Department of Anaesthesia and Intensive Care, ground floor, Main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi

South West
DELHI
110029
India 
Phone  9811270511  
Fax    
Email  charu.bamba@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Charu Bamba 
Designation  Professor and Consultant  
Affiliation  VMMC and Safdarjung Hospital  
Address  Department of Anaesthesia and Intensive Care, ground floor, Main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi


DELHI
110029
India 
Phone  9811270511  
Fax    
Email  charu.bamba@gmail.com  
 
Source of Monetary or Material Support  
VMMC and SAFDARJUNG HOSPITAL  
 
Primary Sponsor  
Name  Vardhaman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi 
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 A Arbika  VMMC and Safdarjung Hospital   Department of Anaesthesia and Intensive Care, ground floor, main it complex, VMMC and Safdarjung Hospital Campus, Ansari Nagar East, New Delhi
South West
DELHI 		 9489574028

arbika21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VMMC and SAFDARJUNG HOSPITAL INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normotensive pregnancy  
Patients  (1) ICD-10 Condition: O149||Unspecified pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Comparator Agent  Normotensive parturients  Ultrasound-based airway assessment parameter- Anterior soft tissue thickness at level of epiglottis (ANS-E) 
Comparator Agent  Preeclamptic parturient  Ultrasound-based airway assessment parameter- Anterior soft tissue thickness at level of epiglottis (ANS-E) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  18-45 years parturient with period of gestation more than 37 weeks ASA II and III with singleton pregnancy. 
 
ExclusionCriteria 
Details  Structural airway abnormalities, tumors and previous head and neck surgery.
Parturients with gestational diabetes, height less than 150 cm, body mass index (BMI) more than 30 kg/m2 (pre-pregnancy). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare ultrasound-based airway assessment parameter- Anterior soft tissue thickness at level of epiglottis (ANS-E) in pre-eclamptic and normotensive parturients.
 		 Ultrasound is used to asses airway parameter- Anterior soft tissue thickness at level of epiglottis (ANS-E) in pre-eclamptic and normotensive parturients.
 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare Ultrasound-Based Airway Assessment Parameters (Hyo-Mental Distance in Neutral Head Position, Tongue Thickness, Pre-E/E-VC, Subglottic Diameter.  To compare the ultrasound based airway assessment parameters in pre-eclamptic and normotensive parturients. 
To Compare Clinical Airway Assessment (Inter Incisor Distance, Modified Mallampati Class, Hyo-Mental Distance, Neck Circumference, Neck Movement and Upper Lip Bite Test) Parameters in Pre-Eclamptic and Normotensive Parturients.  To compare the clinical airway assessment in pre-eclamptic and normotensive parturients.
 
To correlate these ultrasound based airway findings with clinical predictors of difficult airway (MMP greater than 3).  To draw correlation between ultrasound based airway assessment with clinical predictors of difficult airway. 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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   N/A 
Date of First Enrollment (India)   30/09/2025 
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   Difficult or unsuccessful tracheal intubation remains one of the most critical challenges faced by anaesthesiologists, particularly in emergency situations, obstetric cases, or when performed by less experienced practitioners. In obstetric patients, poor management of a difficult airway can lead to neonatal and maternal morbidity and mortality. Pregnancy is associated with various changes in anatomical and physiological changes that can complicate airway management. These include increased body weight, breast enlargement, and fluid retention, all of which contribute to soft tissue swelling and mucosal edema. These changes reduce airway calibre and make intubation more difficult. In hypertensive disorders of pregnancy, such as pre-eclampsia, the upper airway may become even more narrow compared to normotensive pregnant individuals. A variety of clinical tests and scoring systems are used to anticipate airway difficulty, but none—either alone or in combination—provide complete accuracy due to limitations in sensitivity and specificity. Ultrasonography has gained traction as a non-invasive, real-time tool for airway imaging. Ultrasound offers advantages such as real-time visualization, lack of radiation, and the ability to assess hidden airway structures, including the relationship between the tongue and oral cavity—making it a potentially reliable method for difficult airway prediction.

Although ultrasound-based airway assessments have been studied in general adult populations, data specific to pregnant women remains limited. Parameters such as tongue thickness, oral cavity height, and soft tissue dimensions at the epiglottis, vocal cords, and hyoid levels, including the pre-epiglottic space, may offer valuable predictive information.This study aims to evaluate and compare ultrasound-based airway parameters in term normotensive parturients with those in parturients diagnosed with pre-eclampsia. 

 



 
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