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CTRI Number  CTRI/2024/03/064744 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 24/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To assess airway dynamics in prone position in spine surgeries: A Point-of-Care Ultrasound investigation 
Scientific Title of Study   Evaluation of changes in airway parameters using Point of Care Ultrasonography in patients undergoing spine surgery in prone position: A prospective observational 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  Ashita Singh 
Designation  Junior Resident (PG) 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Room no 404, 4th floor, PG Hostel, Department of Anaesthesia and Critical care, AIIMS Bathinda, Mandi Dabwali road, Bathinda, Punjab, 151001, India

Bathinda
PUNJAB
151001
India 
Phone  7518955559  
Fax    
Email  singhashita53@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navneh Samagh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Room number 139, IPD building, first floor, A block, Department of Anaesthesia and Critical care, AIIMS Bathinda, Mandi Dabwali road, Bathinda, Punjab, 151001, India

Bathinda
PUNJAB
151001
India 
Phone  8427264480  
Fax    
Email  navnehsamagh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gopal Krishan Jalwal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Room number 143, IPD building, first floor, A block, Department of Anaesthesia and Critical care, AIIMS Bathinda, Mandi Dabwali road, Bathinda, Punjab, 151001, India

Bathinda
PUNJAB
151001
India 
Phone  7838939833  
Fax    
Email  gopaljalwal@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Critical care, AIIMS Bathinda, Punjab, 151001, India 
 
Primary Sponsor  
Name  Department of Anaesthesia and Critical care AIIMS Bathinda 
Address  All India Institute Of Medical Sciences, AIIMS Bathinda 
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 Ashita Singh  All India Institute of Medical Sciences, AIIMS Bathinda  Department of Anaesthesiology and critical care, All India Institute of Medical Sciences Bathinda, Punjab
Bathinda
PUNJAB 
7518955559

singhashita53@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-NILNIL
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients posted for elective thoracolumbar and lumbosacral spine surgery in the prone position
 
 
ExclusionCriteria 
Details  Patients with oropharyngeal, laryngeal, thyroid and head & neck tumors or growths.
Pregnant patients
Cervical spine injury
Refusal of consent
Patients not extubated at the end of the procedure  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate changes in the anterior neck soft tissue thickness at the level of vocal cords (ANS-VC) as assessed by POCUS in adult patients undergoing spine surgeries in prone position  Pre-operative measurement of ANS-VC using PoCUS, followed by 20 minutes post-extubation of trachea
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare changes in tongue thickness, tongue width, tongue cross-sectional area, neck circumference, Modified Mallampati Class, duration of surgery and intravenous fluids administration   Pre-operative assessment of tongue thickness, width, cross-sectional area, neck circumference, Modified Mallampati class followed by
20 minutes post-extubation of trachea. Duration of surgery and amount of intravenous fluid administered during the surgery will be noted. 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="43" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

Following enrollment, after pre-anaesthesia evaluation, patients posted for spine surgeries in the prone position will be brought to the preoperative area, and we will assess the MMC during airway examination, neck circumference will be assessed using standard measuring tape at the level of cricoid cartilage. An ultrasound machine (Sonosite) Fujifilm Inc. USA) with a low-frequency convex array probe (1–15 MHz) and a high-frequency linear array probe (6–15 MHz) will be used for sonography. A low-frequency ultrasound probe will be placed beneath the chin, along the midline and will be adjusted to obtain a clear visualization of the entire outline of the tongue, as well as the border between the mandible and the hyoid bone on the screen. Once the desired image is achieved, it will be frozen and saved. This frozen image will then be used to measure the cross-sectional area of the tongue by outlining the tongue’s trajectory. Subsequently Tongue Thickness (TT), Tongue width (TW) and Tongue cross-sectional area (TCSA) will be measured.  Finally, a high-frequency ultrasound probe will be placed transversely at the level of the thyrohyoid membrane and adjusted to obtain a clear view of the epiglottis. The epiglottis will appear as a curved, hypoechoic structure, and its image will be frozen and saved. (22)

After shifting the patient inside the operation theatre (OT), we will attach American Society of Anaesthesiologists (ASA) standard monitors i.e., Non-invasive Blood Pressure (NIBP), pulse oximetry (SpO2) and the Electrocardiography ECG electrodes, intravenous fluids (i.v.) will be connected through i.v. lines by securing 2 large bore i.v. cannulas simultaneously. Once the vitals are visualized on the monitors, pre-oxygenation will be started using appropriate size mask for 3 minutes followed by induction with standard induction agents. Patients will be premedicated with injection midazolam 0.01mg/kg. General anaesthesia will be induced with a suitable opioid- fentanyl (2mcg/kg), titrated doses of propofol (1.5 – 2.5mg/kg) and vecuronium 0.1mg/kg. Intubation will be done using an appropriate size cuffed endotracheal tube (8mm for males and 7.5mm for females). Once the airway is secured, bilateral air entry will be confirmed by 5-point chest auscultation and End-Tidal Carbon dioxide (ETCO2) graph. General anaesthesia will be maintained with isoflurane at titrated doses in a mixture of oxygen and nitrous oxide (50:50) and vecuronium. The patients will be ventilated with a tidal volume of 6-8 ml/kg, positive end expiratory pressure (PEEP) will be set at 5 cms of H2O, an inspiratory: expiratory (I:E) ratio of 1:2, and the respiratory rate will be adjusted to maintain an end-tidal carbon dioxide concentration (ETCO2) of 35-40 mm of Hg. Strict temperature monitoring will be done in order to maintain normothermia throughout the surgical procedure. Preloading with deficit fluid (body weight X 1.5ml X hours fasted) will be done to maintain euvolemia before turning the patient to prone position. The mean arterial blood pressure (MAP) will be maintained at more than 60 mm of Hg. After induction on the transport trolley, the patient will be carefully turned to prone position on the operation theatre (OT) table over 2 bolsters, one for the shoulder and other for the iliac crests. The abdomen will be set free. A horse-shoe shaped head support will be used which will ensure a straight head and neck alignment to avoid neck compression, it will provide adequate venous drainage and will reduce kinking of the endotracheal tube. Axilla and knees will be cushioned appropriately with cotton padding to avoid brachial plexus traction or peripheral nerve injuries. All pressure points will be appropriately padded in order to prevent pressure injuries. Eye padding will be used to reduce pressure effects on the eyes and prevent any ocular injuries. The arms will be positioned at < 90 angles at shoulder and axilla. The table will be positioned such that the heart lies above the level of tragus in order to improve cerebral venous drainage.  This position will be maintained throughout the surgery. After the surgery is done, extubation of trachea will be done if the extubation criteria is met using i.v. reversal agents- i.v. neostigmine 0.05 mg/kg and i.v. glycopyrrolate 0.01mg/kg. Monitors will be detached along with the i.v. lines. Within 20 minutes of extubation of trachea, we will measure following parameters using POCUS: ANS-VC, TT, TW AND TCSA and the frozen images will be stored. Next, we will measure neck circumference at the level of cricoid cartilage using standard measuring tape. The duration of anaesthesia and duration of surgery will be noted. The total volume of intravenous fluids used intraoperatively will be noted.

 
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