CTRI Number |
CTRI/2022/03/041133 [Registered on: 16/03/2022] Trial Registered Prospectively |
Last Modified On: |
15/03/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
Checking the efficacy of lung and diaphragm ultrasonography in weaning of patients from mechanical ventilation in intensive care settings |
Scientific Title of Study
|
Use of lung and diaphragm ultrasonography as non-invasive indicators of weaning outcome in intensive care settings: An observational cohort study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sonika Agarwal |
Designation |
Professor |
Affiliation |
Himalayan institute of medical sciences |
Address |
Department of Anaesthesia and Critical care, Swami Rama Himalayan University, HIMS, Jollygrant, Dehradun, Uttarakhand
Dehradun UTTARANCHAL 248140 India |
Phone |
6396918163 |
Fax |
|
Email |
sonikakatiyar@srhu.edu.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Poorva Goyal |
Designation |
Post graduate resident |
Affiliation |
Himalayan institute of medical sciences |
Address |
Department of Anaesthesia and Critical Care, Swami Rama Himalayan University, HIMS, Jollygrant, Dehradun, Uttarakhand
Dehradun UTTARANCHAL 248140 India |
Phone |
7895413661 |
Fax |
|
Email |
poorvagoyal.020595@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Poorva Goyal |
Designation |
Post graduate resident |
Affiliation |
Himalayan institute of medical sciences |
Address |
Department of Anaesthesia and Critical Care, Swami Rama Himalayan University, HIMS, Jollygrant, Dehradun, Uttarakhand
Dehradun UTTARANCHAL 248140 India |
Phone |
7895413661 |
Fax |
|
Email |
poorvagoyal.020595@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesia, Himalayan Institute of Medical Sciences, Swami Ram Nagar, Jollygrant, Dehradun |
|
Primary Sponsor
|
Name |
Himalayan Institute of Medical Sciences |
Address |
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun |
Type of Sponsor |
Private 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 Sonika Agarwal |
Himalayan institute of medical sciences |
Department of anaesthesia and critical care, Swami Rama Himalayan University, HIMS, Jollygrant, Dehradun, Uttarakhand Dehradun UTTARANCHAL |
6396918163
sonikakatiyar@srhu.edu.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
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
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1) Age between 18-65 years,
2) Patients who have been in an intubated state
since a minimum of 48 hours,
3) Excessive tracheobronchial secretions not
present,
4) The underlying critical illness (their reason
for intubation) must have been resolved,
5) Patients fulfilling the criteria of
conventional methods for weaning from
mechanical ventilation.
|
|
ExclusionCriteria |
Details |
1) Hemodynamic instability requiring vasopressors,
2) Gas exchange impairment requiring positive end-
expiratory pressure (PEEP) >10 cmH2O and/or
FIO2 > 50% to obtain a PaO2 > 60 mmHg,
3) Pressure support (PS) level > 20 cmH2O,
4) Deep sedation,
5) History of chronic obstructive pulmonary
disease, neuromuscular disease, anatomical
malformation of the diaphragm or use of muscle
paralyzing agents, aminoglycosides and
corticosteroids,
6) Pneumothorax or pneumomediastinum, increased
intra-abdominal pressure,
7) Aseptic dressings over the chest that can
hamper the process of ultrasonography.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. Sensitivity and specificity of USG indices as predictors of weaning outcome.
2. Positive predictive value (PPV), Negative predictive value (NPV) and diagnostic accuracy of USG indices as predictors of weaning outcome.
|
To check if patient got reintubated within 48 hours post extubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Comparison of traditional indices such as RSBI with USG indices as predictors of difficult weaning |
checking for reintubation within 48 hours after extubation |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
20/03/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
20/03/2022 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Almost 20% of the patients in the intensive care unit (ICU) on mechanical ventilation (MV), experience difficult and prolonged weaning, even after thorough observation and application of the weaning criteria. Conventional methods like regular assessment of breathing frequency, minute ventilation, and negative inspiratory force have little impact in improving the decision of timing of successful extubation. RSBI has been accepted as a successful guide for correct timing of extubation with spontaneous breathing trials. Diaphragmatic dysfunction being a common cause of weaning failure, needs to be assessed during weaning . Ultrasonography has emerged as a promising solution to overcome failed extubations and has been extensively studied over the past few years. USG can easily allow direct visualization of the diaphragm and help us in assessing its contractility and functional efficacy, thus leading to better prediction of weaning outcome and post extubation distress and its cause. Thus, we can gain reassurance over and above the traditional indices for successful weaning.
We formulated a hypothesis that ultrasound guided weaning of a patient from mechanical ventilation may decrease the chances of reintubation. This study aims to prospectively investigate the value of lung and diaphragmatic ultrasonography in the prediction of weaning outcomes and chances of reintubation in patients being weaned from mechanical ventilation and comparing them with the traditional indices for weaning, like RSBI. SAMPLE SIZE: 100 With reference to a previous study(1), the prevalence was taken as 67%. The formula for calculated sample size is given
below: n = (Z 1- α/2 )2 x P(1-P) d2 = (1.96)2 x 0.67(1- 0.67) 0.01 = 84.937 =85 Where, Zα/2 is
the critical value of the Normal distribution at α/2 (e.g., α is 0.1 and the
critical value is 1.96).
85 is the calculated
minimum sample size. METHODS: ·
All patients selected will be the ones already on mechanical ventilation
via an endotracheal tube in situ. ·
Patients will be put to a SBT
when they meet the weaning criteria. Patients will be put on Pressure
Support/CPAP trial for half an hour. Failure of the weaning process shall be defined as a failed
SBT or the need for reintubation/ NIV (non-invasive ventilatory support) within
48 hours following extubation , so all the patients included in the study
will be observed for 48 hours after the SBT. The following weaning indices will
be recorded for all patients during the SBT: Tidal volume (TV), Respiratory
rate (RR), ABG: Po2, Spo2 % and Po2/Fio2, Rapid shallow breathing index: (RSBI
(f/VT) = Respiratory rate/tidal volume. ·
Bedside ultrasound will be performed 20 minutes after initiation of SBT
by a critical care consultant in the ICU, well versed with the use of bedside
lung and abdominal ultrasonography and its interpretation. Initial USG will be done
immediately after putting the patient on SBT to check the anatomy of the
diaphragm and to rule out patients according to exclusion criteria. This will
be followed by a complete diaphragmatic and lung USG after 20 minutes of
initiation of SBT. Three readings shall be recorded for each USG index and an
average value of the three recordings shall be used further. After the extubation, all patients will be
monitored for failed or successful weaning. Weaning will be considered
successful if the patient did not require noninvasive or invasive ventilation
within 48 hours of extubation. At the end of the study, the
patients will be divided into two groups: successful group and failed group (re‑intubation within 48 h after extubation)
according to their response to weaning trials.
The
Diaphragmatic Excursion, Diaphragmatic Thickness Fraction %, diaphragmic contraction (DC), and LUSm( modified Lung Ultrasound Score) score measurements will be
collected for each group and then will be correlated with RSBI.
·
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