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CTRI Number  CTRI/2022/08/044812 [Registered on: 23/08/2022] Trial Registered Prospectively
Last Modified On: 22/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   correlation between weakness in ICU with diaphragm using ultrasound 
Scientific Title of Study   CORRELATION OF INTENSIVE CARE UNIT ACQUIRED WEAKNESS WITH DIAPHRAGMATIC EXCURSION MEASURED BY USG. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrvishnuR 
Designation  junior resident 
Affiliation  PGIMER chandigarh 
Address  junior resident, dept. of Anaesthesia and intensive care PGIMER , Chandigarh
dept. of Anaesthesia and intensive care PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  8197219150  
Fax    
Email  eekvis@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Drvikas saini 
Designation  professor 
Affiliation  PGIMER chandigarh 
Address  professor, dept. of Anaesthesia and intensive care PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8197219150  
Fax    
Email  drvsaini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrvishnuR 
Designation  junior resident 
Affiliation  PGIMER chandigarh 
Address  junior resident, dept. of Anaesthesia and intensive care PGIMER , Chandigarh
dept. of Anaesthesia and intensive care PGIMER , Chandigarh

CHANDIGARH
160012
India 
Phone  8197219150  
Fax    
Email  eekvis@gmail.com  
 
Source of Monetary or Material Support  
PGIMER, CHANDIGARH 
 
Primary Sponsor  
Name  PGIMER  
Address  PGIMER CHANDIGARH  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
drvishnuR  MAIN INTENSIVE CARE UNIT PGIMER   dept of anaesthesia and intensive care , level 1 neharu hospital ,
Chandigarh
CHANDIGARH 
8197219150

eekvis@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE PGIMER, CHANDIGARH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G729||Myopathy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients in the age group of 18-65 years.
Patient admitted MAIN ICU OR tetanus ICU and mechanically Ventilated for more than 48hrs 
 
ExclusionCriteria 
Details  Patients with known neuromuscular disorders and anatomical malformations of the thorax.
Patient with a previous central or peripheral neurological lesion.
Patients with spinal and brachial plexus injury.
A patient has ≤ 2 limbs in which muscle power cannot be tested.
h/o recent fracture of limbs or other skeletal injuries.
Patients with a neuro-paralytic snake bite. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the correlation between MRC sum score and diaphragmatic excursion measured
using USG. 
To assess the correlation between MRC sum score and diaphragmatic excursion measured
using USG. 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the diagnostic abilities of diaphragmatic excursion and MRC scores in mechanically ventilated ICU patients undergoing a first spontaneous breathing trial(SBT).

To assess the correlation between age use of Neuromuscular blockers, and severity of illness at the time of admission to ICU on the incidence of ICUAW. 
at the time of SBT 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
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)   24/08/2022 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Intensive care unit (ICU) acquired muscle weakness (ICUAW) is a clinically detected
condition characterized by diffuse, symmetric weakness involving the limbs and respiratory
muscles Patients have different degrees of limb muscle weakness and are dependent on a
ventilator, while the facial muscles are spared. Diagnosis of ICUAW requires that no
plausible etiology other than critical illness be identified, and thus, other causes of acute
muscle weakness is excluded. One major diagnostic criterion is that ICUAW is detected
after the onset of critical illness.
ICUAW is a multifactorial disease the risk factors include female gender duration of
mechanical ventilation, glucocorticoids therapy, persistent hyperglycemia, multiorgan
system failure, sepsis, use of neuromuscular blockers during the ICU stay2,3,1
ICUAW is a clinically relevant complication during the acute stage of disease and after
discharge from the acute-care hospital. In the ICU, severe muscle weakness is independently
associated with prolonged mechanical ventilation, ICU stays, hospital stays, and increased
mortality Patients developing weakness during the ICU stay have reduced quality of life and
increased mortality 1 year after ICU discharge.

A diagnosis of ICUAW is achieved by manually testing the muscle strength using the
Medical Research Council scale. MRC muscle strength is assessed in 12 muscle groups,
(wrist flexion, forearm flexion, shoulder abduction, ankle dorsiflexion, knee extension, and
hip flexion), the total score ranges from 0 (complete paralysis) to 60 (normal muscle strength)
a summed score below 48/60 designates ICUAW or significant weakness, and an MRC score
below 36/48 indicates severe weakness But this requires full patient cooperation and a fully
conscious patient which is not always the case in ICU because of the use of sedation.
Respiratory muscles are often involved in ICUAW. The diaphragm is a major respiratory
muscle accounting for 80% of inspiratory function assessment of diaphragm weakness is a
useful tool in assessing ICUAW.
Bedside ultrasonography, which is already crucial in several aspects of critical illness has
been recently proposed as a simple, non-invasive method of quantification of diaphragmatic
contractile activity. Ultrasound can be used to determine diaphragm excursion using M
mode Ultrasonography of the diaphragm may be useful in identifying patients with
diaphragmatic weakness which may lead to prolonged weaning Diaphragmatic excursion using M mode can be measured in both hemidiaphragm, during
quiet breathing, deep breathing, and voluntary sniff. Normal values of excursion vary with
age and gender position of the patient, In supine position. The lower limit values for the right
hemidiaphragm were close to 1.1 cm for women and 1.2 cm for men during quiet breathing,
1.6 cm for women and 1.8 cm for men during voluntary sniffing, and 3.7 cm for women and
4.7 cm for men during deep breathing7
Not all patients who are weaned in ICU off ventilator have diaphragm weakness, they may
have poor muscle power or MRC score. in this study, we plan to find a correlation
between diaphragmatic excursion using ultrasound with MRC sum score which has not been
done in earlier studies. We hypothesize that the degree of respiratory weakness correlates
with the degree of limb weakness measured using the MRC sum score. And we can use
diaphragmatic excursion to predict the presence of ICUAW.
 
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