| CTRI Number |
CTRI/2023/11/060183 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of focused neck ultrasound in evaluating airway difficulty. |
|
Scientific Title of Study
|
Clinical evaluation of targeted airway ultrasound in determining difficult video laryngoscopy. |
| 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 KALYANI MANASA RAPETI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Center |
| Address |
Department of Anesthesiology, critical care and Pain, 2nd floor, OT complex, Homi Bhabha Cancer Hospital and Research Center, VISAKHAPATNAM
PAC clinic, OPD building, Homi Bhabha Cancer Hospital and Research Center, VISAKAHAPATNAM
Visakhapatnam
ANDHRA PRADESH
530046
India |
| Phone |
07989566620 |
| Fax |
|
| Email |
rapeti.kalyanimanasa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KALYANI MANASA RAPETI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Center |
| Address |
Department of Anesthesiology, critical care and Pain, 2nd floor, OT complex, Homi Bhabha Cancer Hospital and Research Center, VISAKHAPATNAM
PAC clinic, OPD building, Homi Bhabha Cancer Hospital and Research Center, VISAKAHAPATNAM
Visakhapatnam
ANDHRA PRADESH
530046
India |
| Phone |
07989566620 |
| Fax |
|
| Email |
rapeti.kalyanimanasa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KALYANI MANASA RAPETI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Center |
| Address |
Department of Anesthesiology, critical care and Pain, 2nd floor, OT complex, Homi Bhabha Cancer Hospital and Research Center, VISAKHAPATNAM
PAC clinic, OPD block, ground floor, Homi Bhabha Cancer Hospital and Research Center, VISAKAHAPATNAM
Visakhapatnam
ANDHRA PRADESH
530046
India |
| Phone |
07989566620 |
| Fax |
|
| Email |
rapeti.kalyanimanasa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homibhabha cancer hospital and research center, Visakhapatnam |
|
|
Primary Sponsor
|
| Name |
Homibhabha cancer hospital and research center |
| Address |
Homibhabha cancer hospital and research center, a unit of DAE, Visakhapatnam, Andhra Pradesh |
| 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 |
| KALYANI MANASA RAPETI |
HBCHRC |
HBCHRC, VISAKHAPATNAM
Visakhapatnam
ANDHRA PRADESH |
7989566620
rapeti.kalyanimanasa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HBCHRC ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, (3) ICD-10 Condition: C402||Malignant neoplasm of long bones of lower limb, (4) ICD-10 Condition: C153||Malignant neoplasm of upper thirdof esophagus, (5) ICD-10 Condition: C689||Malignant neoplasm of urinary organ, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients(> 18 years) planned for elective surgery under neuromuscular relaxation with orotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Restricted mouth opening <3cm
Nasotracheal intubation
Prior irradiation to the head and neck region
BMI >35kgm-2
Extra axial mass in the neck and/or demonstrated intraluminal airway obstruction including tongue and laryngeal malignancies.
Physiologically difficult airway
Suspected or proven airway hemorrhage
Room air saturation < 95% at room air
Inability and Unwillingness to provide informed consent.
Patients at risk of aspiration of gastric contents |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of airway ultrasound parameters over conventional airway assessment in predicting difficult airway using video laryngoscope as endpoint of intervention |
At baseline after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of clinical predictors over airway ultrasound |
1 year |
|
|
Target Sample Size
|
Total Sample Size="435"
Sample Size from India="435"
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)
|
02/12/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study aims to evaluate focused airway ultrasound ability to assess the difficult airway prediction, and its valuation using video laryngoscopy as the final correlation in the determination of airway difficulty assessment efficacy. |