| CTRI Number |
CTRI/2025/05/087797 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasonography to confirm endotracheal intubation and the position of endotracheal tube. |
|
Scientific Title of Study
|
An observational study on the use of ultrasonography to confirm endotracheal intubation and the position of endotracheal tube in comparison to conventional methods in adult patients admitted under intensive care unit. |
| 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 Priya manjunath shetty |
| Designation |
junior resident |
| Affiliation |
Shri B M patil medical college, hospital and research centre |
| Address |
Department of anesthesiology, 3rd floor, shri B M Patil medical college, hospital and research centre, vijayapura, Karnataka , India
Bijapur
KARNATAKA
586103
India |
| Phone |
9632787261 |
| Fax |
|
| Email |
ps99033@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivanand karigar |
| Designation |
associate professor |
| Affiliation |
Shri B M patil medical college and research centre |
| Address |
Department of anesthesiology, 3rd floor, shri B M Patil medical college, hospital and research centre, vijayapura, Karnataka, India
Bijapur
KARNATAKA
586103
India |
| Phone |
9164319345 |
| Fax |
|
| Email |
Shivanandkarigar82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Manjunath shetty |
| Designation |
Junior resident |
| Affiliation |
Shri B M patil medical college, hospital and research centre |
| Address |
department of anesthesiology, 3rd floor, Shri B M patil medical college, hospital and research centre, vijayapura,Karnataka, India
Bijapur
KARNATAKA
586103
India |
| Phone |
9632787261 |
| Fax |
|
| Email |
ps99033@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Priya manjunath shetty |
| Address |
Shri B M patil medical college and research centre, Solapur Road, Vijaypura |
| Type of Sponsor |
Other [self] |
|
|
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 Priya manjunath shetty |
Shri B M patil medical college, hospital and research centre |
Department of anesthesiology, shri B M patil medical college and research centre, vijayapura, Karnataka, India 586103
Bijapur
KARNATAKA |
9632787261
ps99033@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE (deemed to be university) institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional endotracheal intubation in patients admitted under intensive care unit |
after intubation, An AP chest X-ray will be used to confirm the final positioning of the tube tip when the patient is semi-recumbent on the bed and the neck is in neutral posture. The ideal site for the ETT tip on an X-ray is between the sternoclavicular joint superiorly and at least 4 cm above the carina inferiorly, which helps establish whether the tube position is adequate. The ETT tips distance from the carina on the X-ray chest AP image will be measured with a digital calliper. [3] |
| Comparator Agent |
USG guided endotracheal tube intubation in patients admitted under intensive care unit |
During intubation, the transverse placement of the linear probe (13-6 MHz Sonosite M-Turbo®) over the trachea between the suprasternal notch and the cricothyroid membrane will be noted. The presence or absence of the snow storm sign (disturbance of the tracheal air-mucosa interface with comet tail artefacts) will be reported (figure 1).
An attempt will be made to detect the oesophageal opening via ultrasonography, and the presence of the double track sign (figure 2) and the lack of absence of snow storm sign loss will indicate oesophageal intubation.
In case the double track sign in present, an attempt to reintubation will be done till there is absence of snow storm sign that signifies endotracheal intubation.
After endotracheal intubation is verified by waveform capnography, To detect the cricoid cartilage and the tracheal rings, a sagittal plane ultrasonography of the trachea will be conducted.
The ETT cuff will be fully deflated and reinflated with 10cc of regular saline. The ETT cuff in the trachea will be recognized as an anechoic shadow. The cuffs top end will be secured at the level of the third or fourth tracheal ring.
To maintain intracuff pressures between 20 and 25 cm H2O (with cuff pressure monitor) , the saline from the ETT cuff will be aspirated and the cuff will be re-inflated with air after the tube has been finally placed. [3]
(In order to calculate the saline volume, we conducted a few pilot cases. We discovered that 10 cc of saline was suitable for ultrasound visualization of the tube cuff and was not linked to elevated cuff pressures.)
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
patients under going endotracheal intubation in intensive care unit |
|
| ExclusionCriteria |
| Details |
BMI more than 30, patients with suspected or confirmed cervical spine injury with cervical collar in place, patients intubated with uncured ETT |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to know the accuracy of ETT confirmation and correct position between the two groups, to compare the time taken for confirmation of ETT placement between the two groups |
every 2 hours I will confirm the position of ETT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to know the cost effectiveness between the two groups, reducing the time required for confirmation of ETT placement, to know the incidence and accidental extubation or displacement of ETT due to patient movement |
every 2nd day I will confirm the number of x rays done |
|
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Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
10/06/2025 |
| 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="0"
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
|
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Brief Summary
|
General physical examination, airway assessment and systemic examination will be conducted. Standard monitoring of hemodynamic parameters ( blood pressure, pulse rate, saturation, respiration rate) to be applied, patient will be assessed based on APACHE II scoring system.Assessment of patient’s GCS (glasgow come scale) . trained anaesthesiologist group or intensivist will perform all procedures to eliminate any possible complications.Under all aseptic condition, trained anaesthesiologist will proceed to intubate the patient. Upper airway ultrasonography will be performed during intubation, The linear probe (13-6 MHz) will placed transversely over trachea between suprasternal notch and cricothyroid membrane.absence of snow storm sign will be reported as tracheal intubation.oesophageal intubation will identified by appearance of double track sign. Endotracheal intubation will be confirmed with waveform capnography. Ultrasound of trachea will be performed again in sagittal plane to identify the cricoid cartilage and the tracheal rings. The ETT cuff will be fully deflated before being reinflated with 10cc of regular saline. The ETT cuff in the trachea will be recognized as an anechoic shadow. The cuff’s top end will be secured at the level of the third or fourth tracheal ring. Following the final tube installation, the ETT cuff’s saline will be aspirated, and the cuff will be reinflated with air to keep the intracuff pressure between 20 and 25 cm H2O. |