| CTRI Number |
CTRI/2022/05/042859 [Registered on: 27/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A new technique to identify correct placement of endotracheal tube. |
|
Scientific Title of Study
|
Positive Predictive Value of the Presence of Endotracheal(ETT) cuff ballotability above the Suprasternal notch in diagnosing the Correct positioning of ETT(PRESeNCE)-A prospective Observational study |
| Trial Acronym |
PRESeNCE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Bhagat |
| Designation |
Professor of Neuroanesthesia |
| Affiliation |
PGIMER |
| Address |
Professor,
Department of neuroanesthesia,
PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
hembhagat@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Bhagat |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Professor,
Department of neuroanesthesia,
PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
hembhagat@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viswanath S |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Anesthesia,
PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9524060300 |
| Fax |
|
| Email |
sviswanath20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Postgraduate Institute of Medical education and research, Chandigarh- 160012 |
| Type of Sponsor |
Research institution |
|
|
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 Hemant Bhagat |
Department of Neuroradiology, DSA suite |
Interventional Radiologhy,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9216387387
hembhagat@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are undergoing any procedure in Digital Subtraction Angiography(DSA) suite under General Anesthesia.
BMI< 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Obesity
Cervical collar in place
Presence of mass in front of neck
Previous history of radiation to neck
Patient refusal to study
Inability to visualise the Endotracheal tube cuff in x ray/ fluoroscopy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether the Endotracheal tube(ETT) cuff ballotability over the suprasternal notch accurately predicts the correct placement of ETT. |
single time, with the data collected after the induction of General Anesthesia in all subjects. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the Positive Value of the Presence of endotracheal tube cuff ballotability above the Suprasternal notch for correct positioning of the ETT. |
1 |
| To find the sensitivity and specificity of cuff ballotability for correct positioning of ETT. |
Single time, done with the data collected after induction of general anesthesia in patients. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2022 |
| Date of Study Completion (India) |
15/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Endotracheal intubation is one of the most common procedures used by anesthesiologists, intensivists and emergency personnel. But it can be associated with complications, such as carinal impingement or endobronchial intubation, which leads to increased incidence of barotrauma, contralateral lung collapse, or both, which result in hypoxemia and hemodynamic instability.
Three types of malposition can occur during intubation: one outside the trachea (esophageal), and two within the trachea: too shallow (hypopharyngeal/transglottic cuff), or too deep (endobronchial).
The various other methods for determining Endotracheal tube(ETT) placement are bilateral chest auscultation of equal air entry, chest X ray, fiberoptic bronchoscopy, capnography. However, these techniques are quite limited in actual clinical practice.
Ballotability of the ETT cuff over the anterior part of trachea above the supersternal space of Burns, could be a novel technique to confirm the proper ETT position.
Hence considering the simplicity of this test and its bedside/point of care utility, we propose to investigate this method of cuff ballotment to verify the correct ETT position and to explore its sensitivity, specificity, positive and negative predictive value when compared with the gold standard of cervicothoracic Xray.
|