| CTRI Number |
CTRI/2025/07/091066 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The study on certain physical measurements (like head size, neck size, etc.) which can help predict if a newborn baby might have trouble with breathing or intubation (inserting a tube to help them breathe). |
|
Scientific Title of Study
|
An observational study on anthropometric airway parameters as predictive indicators of neonatal difficult airway |
| 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 Neelam Dogra |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia, SMS medical college and attached hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928709289 |
| Fax |
|
| Email |
neelam_dogra24@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Dogra |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia, SMS medical college and attached hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928709289 |
| Fax |
|
| Email |
neelam_dogra24@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi Agarwal |
| Designation |
Resident doctor |
| Affiliation |
SMS medical college |
| Address |
Department of Anaesthesia, SMS medical college and attached hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7597965813 |
| Fax |
|
| Email |
agrawal.ayushi78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, SMS medical college and attached hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Sawai nan singh medical college and attached hospitals |
| Address |
Department of Anaesthesia Sawai man Singh medical college and attached hospitals Jaipur 302004 |
| Type of Sponsor |
Government medical college |
|
|
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 Neelam Dogra |
SMS medical college and attached hospitals jaipur |
Department of Anaesthesia, SMS medical college and attached hospitals jaipur,302004
Jaipur
RAJASTHAN |
9928709289
Neelam_dogra24@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics committee SMS MEDICAL COLLEGE and attached hospitals Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84-P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Parents or guardians willing to give consent for study, ASA grade I and II, elective or emergency non cardiac surgery under general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Syndromes babies, neonates with congenital maxillofacial defects, neonates with upper airway pathology and neck swellings |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the accuracy of the ratio of frontal plane to chin distance by weight (FPCD/ Weight) to predict difficult laryngoscopy and difficult intubation among neonates. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the accuracy of various anthropometric parameters like age, weight, head circumference (HC), neck circumference (NC), thyromental distance (TMD), sternomental distance (SMD) & Frontal plane to chin distance (FPCD) to predict difficult laryngoscopy & difficult intubation among neonates |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/08/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To evaluate the accuracy of various anthropometric parameters (age, weight, neck circumference, headcircumference, thyromental distance, sternomental distance, frontal plane to chin distance, and frontal plane to chin distance by weight ratio) in predicting difficult laryngoscopy and intubation among neonates undergoing elective / emergency non cardiac surgery under general anaesthesia requiring endotracheal intubation. For this a total of 70 neonates (n=70) undergoing elective / emergency non cardiac surgery under general anaesthesia requiring endotracheal intubation satisfying inclusion criteria were selected. Informed and written consent from parents of neonates was taken. PAC, NBM status checked, and patient was shifted to OT . Age, weight, anthropometeric parameters assessed before induction (Head circumference , Neck circumference, Thyromental distance , Sternomental distance , Frontal plane to chin distance) and readings were kept in sequentially numbered opaque envelopes. Routine monitors will be attached, baseline parameters (BP, PR, SPO2) will be recorded, intravenous fluid will be started through already secured cannula as per hospital protocol. Patients will be premedicated with Inj. Glycopyrrolate 0.005mg/kg, Inj. Fentanyl 1mcg/ kg. Induction will be done with Inj. Thiopentone 5 mg/kg. Inj. Succinylcholine 1.5 mg/kg. Mask ventilation will be performed, Larngoscopy will be done by Miller blade size 0 by a anaesthetist blinded to previously recorded readings. CL grading, IDS score will be noted and kept in another set of sequentially numbered opaque envelopes. Anaesthesia will be maintained with O2 + Air (50:50) + Sevoflurane (MAC 1-2) + relaxant Inj. Atracurium 0.5 mg/kg loading dose and 0.1 mg/kg maintenance dose sos. Intraoperative analgesia was maintained using inj. fentanyl citrate 2 mcg/kg. IPPV will be performed, on completin of surgery reversal agent (inj. Neostigmine 0.07mg/kg+ inj. Glycopyrrolate 0.001mg/kg) will begiven and patient will be extubated after satisfying extubation criteria and pt.will be shifted to recovery room. |