| CTRI Number |
CTRI/2024/08/072553 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing between diaphragmatic and parasternal muscle thickness using Ultrasonography for predicting weaning in intubated patients. |
|
Scientific Title of Study
|
Comparative analysis of diaphragmatic thickness fraction with parasternal muscle thickness fraction by the use of ultrasonography for predicting weaning in adults receiving mechanical ventilation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arushi Sharma |
| Designation |
Postgraduate student |
| Affiliation |
Govt Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care,Block-D,Level-5 GMCH,Sector 32-B
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
6280715953 |
| Fax |
|
| Email |
arushiaks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Saroa |
| Designation |
Professor |
| Affiliation |
Govenment medical college and hospital, Sector 32-B Chandigarh P.O-160030 India |
| Address |
Department of Anaesthesia and Intensive Care,Block-D,Level-5 GMCH,Sector 32-B
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Palta |
| Designation |
Professor and Head of department |
| Affiliation |
Govenment medical college and hospital, Sector 32-B Chandigarh P.O-160030 India |
| Address |
Department of Anaesthesia and Intensive Care,Block-D,Level-5 GMCH,Sector 32-B
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH sector 32 B Chandigarh, India, Pincode 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5,
GMCH, Sector 32B, Chandigarh, India, Pincode- 160030 |
| 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 Arushi Sharma |
Government Medical college and Hospital, Chandigarh |
Department of Anaesthesia and Intensive care, block D, Level -5, GMCH, Sector-32 B, Chandigarh
Chandigarh
CHANDIGARH |
6280715953
arushiaks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG diaphragmatic parameters and parasternal muscle thickness |
The ultrasound derived parameters will be performed in all the patients included in the trial and will be compared with each other to ascertain as to which parameter predicts weaning in mechanically ventilated patients. the parameters will be correlated to ventilatory derived parameters. Since all parameter will be performed in all patients, the present study will be a single arm study.
All the Diaphragmatic
ultrasounds in ICU
will be performed by using high frequency linear array probe 6to12 MHz.All the measurements will be made by the same anesthesiologist and the findings of the ultrasound will not be disclosed to the anesthesiologist recording the ventilator derived parameters.
Following observations will be drawn from the diaphragm ultrasound:
1.Diaphragm thickness at end of inspiration i and expiration e
2.Amplitude AMP in centimeters cm will be measured.
3.The diaphragm thickness fraction in percentage will be calculated as the difference between diaphragmatic thickness at inspiration and diaphragm thickness expiration divided by
diaphragm thickness at expiration multiply by100.
Parasternal muscle ultrasound
An ultrasound of the second intercostal muscle ultrasound will be performed.The thickness of parasternal intercostals will be calculated with a high frequency 6to12 MHz USG probe at the level of the second intercostal space 6 to 8 cm away from the sternal edge to visualize the second and third ribs.Then, M mode will be used to measure the thickness at the end of inspiration and expiration. The average of three consecutive readings will be used for analysis. The maximum and minimum thickness of the parasternal intercostals during three consecutive tidal breaths will be taken and averaged. Then, the PICTF percentage will be calculated using the following formula:Maximum minus minimum thickness by minimum thickness expressed as a percentage. All the respiratory muscle analysis will be done after a 120-minute SBT.
PICTF percentage will be measured as peak thickness at inspiration minus end expiratory thickness divided by end-expiratory thickness.multiply by 100.
All the readings derived from ventilator derived parameters as well as the diaphragmatic and parasternal derived parameters by independent observers will be decoded at the end of the study for the statistical analysis and appropriate correlation with weaning.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All the patients with age more than 18 years
patients receiving mechanical ventilation in process of weaning from the same |
|
| ExclusionCriteria |
| Details |
Patients with following will be excluded from the study
Diaphragmatic paralysis/injury,
neuromuscular disease,
pregnant women,
lactating/nursing mothers
Patients aged less than 18 years.
Received mechanical ventilation for less than 24 hrs.
Preexisting diaphragm disease.
Any breach in skin preventing DUS examination in subcostal area.
Phrenic nerve palsy.
Refusal of consent |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of diaphragmatic thickness with parasternal muscle thickness using ultrasonography for
predicting weaning in patients receiving mechanical ventilation in ICU
usg measured diaghragmatic muscle thickess fraction and parasternal thickness fraction will be measured and the outcomes of two will be compared in all patients
|
From starting of weaning process at predefined time intervals every day twice moring and evening till 24 hours post successful extubation diaphragmatic and parasternal muscle thickness will be measured using ultrasound.
3 readings each in morning and evening will be taken for both diaphragmatic and parasternal muscle thickness. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To measure diaphragm movement derived parameters i.e .Amplitude [AMP] in centimeters
(cm), thickness of muscle during inspiration and expiration.
2. To measure parasternal muscle derived parameters i.e thickness of muscle during
inspiration and expiration.
3. To observe the values of Rapid Shallow Breathing Index,Negative Inspiratory Force &
occlusion pressure during weaning.
4. To compare the sensitivity,specificity ,positive predictive value, negative predictive value
and length of stay with all parameters |
From starting of weaning process till 24 hours post successful extubation.
3 readings of morning evening and night each day. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="6"
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
|
Mechanical ventilation has emerged as commonly used tool in saving lives of patients experiencing heightened work of breathing with altered pulmonary gas exchange for effective ventilation and oxygenation. Weaning is the process of gradually reducing ventilator assistance so that spontaneous respiration can be restored. Traditionally ventilator derived factors like the RSBI (rapid shallow breathing index), Tracheal occlusion airway pressure, NIF (negative inspiratory force) index and other indices, along with clinical criteria that monitor the respiratory rate and oxygenation, have been studied and often utilized to guide successful weaning. Recently ultrasound guided parameters are being used. USG guided measurement of diaphragmatic and parasternal muscle thickness being the most widely used index.
Conduct Of Study Once the weaning criteria has been attained, patients will be subjected to recording of conventional ventilator derived parameters which are rapid shallow breathing index (RSBI), Negative inspiratory Force (NIF) and Occlusion Pressure (P0.1), RSBI values less than 105, NIF values less than or equal to 25, occlusion pressure value less than 4.2cm H2O as well as ultrasound derived diaphragmatic and parasternal parameters to predict the successful weaning. All the parameters will be recorded from the day a particular patient is initiated on CPAP/ASB mode of ventilation. All the ultrasonography parameters will be noted twice a day and ventilator derived parameter will be noted once a day starting from day of weaning to complete discontinuation of mechanical ventilation for at least 24 hours which will be considered as successful weaning. In the ultrasound guided intervention diaphragm thickness and parasternal thickness derived parameters will be recorded twice a day. Each time mean of three readings of diaphragm and parasternal derived parameters will be taken in the observations. The number of patients requiring reintubation will also be noted. At the end of study, the data will be decoded and analyzed accordingly. Technique of diaphragm ultrasound: All the Diaphragmatic ultrasounds in ICU will be performed by an experienced anesthesiologist using high frequency linear array probe of 6 to 12 MHz. The probe will be placed in the right subcostal margin between the mid clavicular and anterior axillary line, parallel to the excursion of the diaphragm. 2D B mode will be used to search the line of right hemidiaphragm. The diaphragmatic excursions will be measured in M mode from baseline to point of maximum height of inspiration at the zone of apposition of diaphragm and rib cage. Diaphragm thickness will be measured in the zone of apposition of the diaphragm and rib cage in the mid axillary line between the eighth and tenth intercostal space by placing the curvilinear probe allowing placement of M mode line parallel to the excursion of the diaphragm. MEASUREMENTS: Following observations will be drawn from the diaphragm ultrasound: 1 Diaphragm thickness at end of inspiration and expiration 2 Amplitude AMP in centimeters will be measured. 3 The diaphragm thickness fraction in percentage will be calculated as the difference between diaphragm thickness at inspiration and diaphragm thickness expiration divided by diaphragm thickness at expiration multiply by 100. Technique of parasternal ultrasound An ultrasound of the second intercostal muscle ultrasound will be performed. The thickness of parasternal intercostals will be calculated with a high frequency of 6to 12 MHz USG probe at the level of the second intercostal space, 6 to 8 cm away from the sternal edge to visualize the second and third ribs. Then, M-mode will be used to measure the thickness at the end of inspiration and expiration. The average of three consecutive readings will be used for analysis. The maximum and minimum thickness of the parasternal intercostals during three consecutive tidal breaths will be taken and averaged. Then, the PICTF in percentage will be calculated using the following formula: Maximum–minimum thickness/minimum thickness, expressed as a percentage. All the respiratory muscle analysis will be done after a 120 minute SBT. PICTF percentage will be measured as peak thickness at inspiration minus end-expiratory thickness divided by end-expiratory thickness multiply by 100.
All the observations will be noted in the prescribed performa. Utrasound derived diaphragmatic and parasternal factors used for weaning will be noted and comapritive analysis between the two will be done. |