| CTRI Number |
CTRI/2025/02/080866 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study betwwen techniques to predict post extubation obstruction in the airway |
|
Scientific Title of Study
|
A comparative study to evaluate the accuracy between cuff leak test & bedside laryngeal ultrasound in predicting post extubation stridor by intensivist- a prospective randomized comparative 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 |
Dr Sathya NarayananK |
| Designation |
DM Critical care medicine , senior resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
DEPARTMENT OF CRITICL CARE MEDICINE
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
09597447444 |
| Fax |
|
| Email |
sathyavaan4444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIJAYA KUMAR |
| Designation |
Professor and Head incharge , Department of critical care medicine |
| Affiliation |
Bangalore Medical College and Research Institute, Bangalore - BANGALORE |
| Address |
Department of Critical Care Medicine , 5th floor , Trauma and emergency care centre , Bangalore Medical College
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
09597447444 |
| Fax |
|
| Email |
viji2751977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathya NarayananK |
| Designation |
DM critical care medicine , senior resident |
| Affiliation |
Bangalore Medical College and Research Institute, Bangalore |
| Address |
Department of Critical Care Medicine , 5th floor , Trauma and emergency care centre , Bangalore Medical College
BANGALORE
Bangalore
KARNATAKA
560022
India |
| Phone |
09597447444 |
| Fax |
|
| Email |
sathyavaan4444@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college & Research institute, Karnataka ,India pin code - 560022 |
|
|
Primary Sponsor
|
| Name |
Sathya Narayanan K |
| Address |
Department of Critical Care Medicine , 5th floor , Trauma and emergency care centre , Bangalore Medical College , BMCRI , Bangalore , Karnataka, India - 560022 |
| 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 |
| DrSathya NarayananK |
Bangalore Medical College & Research Institute |
Department of Critical Care Medicine , 5th floor , Trauma and emergency care centre , Bangalore Medical College, Fort, K.R. Road, Bangalore, Karnataka, India · 560 002 · Krishna Rajendra Road
Bangalore
KARNATAKA |
9597447444
dr.satnark@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Bangalore Medical College & Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J050||Acute obstructive laryngitis [croup], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cuff leak |
The cuff leak test, which depicts a leak around the endotracheal tube with the cuff deflated will predict the presence of PES. A lower amount of cuff leaks indicates a population at higher risk of developing PES. The cuff leak test will be performed as described below. The throat is cleared of all airway secretions. The ventilator is set to assist-control.The inspiratory and expiratory tidal volumes will be recorded and then the cuff is deflated. The expiratory tidal volumes will be recorded over the next six breathing cycles. The six expiratory volumes will be recorded and average the three lowest values is calculated. The cuff leak is the difference between the inspiratory tidal volume and the average expiratory tidal volume. All of the patients will be extubated when the cuff leak volume exceeds more than 110 ml and when they pass weaning trial. |
| Intervention |
laryngeal ultrasound with air column width |
Laryngeal ultrasound will be performed by an intensivist with an experience of performing more than 100 laryngeal US using a 5.0 MHz linear probe to measure air column width (defined as the width of air passed through the vocal cords (VC) as determined by ultrasound (US)). Air column width will be measured with the probe placed on the cricothyroid membrane with a transverse view of the larynx and patient positioned supine with a neck hyperextended and ETT cuff deflated. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Prolonged intubated state more than 3 days
Prolonged intubation attempts more than 10 minutes
Airway injury due to trauma or during intubation
Airway surgery
Recurrent Intubations
Self- extubation with the cuff still inflated
|
|
| ExclusionCriteria |
| Details |
Patients primarily intubated for the upper airway obstruction, having risk factor for tracheomalacia, or vocal cord paralysis with clinical presentation of stridor were excluded
Patients or Parents or Caregivers refusal to give informed consent.
Patients less than 18 years of age
Neuromuscular diseases
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity, Specificity, Positive predictive value and Negative predictive value of Air column width difference , Air column width ratio and cuff leak test in patients prone for post extubation stridor. |
0 minutes after admission ,at 1 day before extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The incidence of Post extubation stridor
|
at 2nd day of icu admission |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
01/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sathyavaan4444@gmail.com].
- For how long will this data be available start date provided 15-02-2025 and end date provided 01-08-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Post-extubation stridor (PES) is the presence of inspiratory noise which develops post-extubation indicating narrowing of the airway with an incidence of 3-30%.[1]PES results in airway obstruction and respiratory distress which further accentuates hemodynamic instability and cardiac failure.[2] Stridor also results in negative pressure pulmonary oedema.[3] Risk Factors associated with PES includes older age, female gender, size of the endotracheal tube, prolonged intubation period, traumatic intubation and multiple intubation attempts. All of these can increase the mortality and morbidity, prolong the length of intensive care unit (ICU) stay and mechanical ventilation.Prior detection of PES prevents the need for reintubation, facilitates early treatment and recovery. The diagnosis of PES is critical as these patients can benefit from attentive monitoring and targeted therapy. Nonetheless, there is no consensus on how to identify patients at risk of PES. Cuff leak test demonstrates leak around the endotracheal tube when the cuff is deflated and is one of the simplest method proposed for predicting the occurrence of post extubation stridor. Ultrasound is bedside noninvasive tool in visualizing upper airway. The Air Column Width Difference predicts the occurrence of post extubation stridor.[4] The lacunae in the previous studies done to predict post extubation stridor had fewer patients in stridor group resulting in lower sensitivity. |