| CTRI Number |
CTRI/2023/10/059176 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Testing of respiratory muscle strength in mechanically ventilated patients in intensive care unit. |
|
Scientific Title of Study
|
Assessment of Respiratory Muscle Strength in Mechanically Ventilated patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahana S |
| Designation |
Post Graduate Student |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy, Department of Physiotherapy, 3rd floor, M.S.R Nagar MSRIT post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
7338413544 |
| Fax |
|
| Email |
sahanashankar19101999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Shaswat Verma |
| Designation |
Assistant Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy Department of Physiotherapy, 3rd floor, M.S.R Nagar, MSRIT post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886591748 |
| Fax |
|
| Email |
shaswatverma.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Shaswat Verma |
| Designation |
Assistant Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy Department of Physiotherapy, 3rd floor, M.S.R Nagar, MSRIT post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886591748 |
| Fax |
|
| Email |
shaswatverma.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah College Of Physiotherapy and
Ramaiah medical college and Hospitals, M.S.R Nagar MSRIT branch Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
Sahana S |
| Address |
Ramaiah College Of Physiotherapy, M S R Nagara, M.S.R.I.T branch Bangalore 560022 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shaswat Verma |
Ramaiah Medical College and Hospital |
Department of Physiotherapy, 3rd floor, M S Ramaiah Nagara, MSRIT Post, Bangalore
Bangalore
KARNATAKA |
7338413544
sahanashankar19101999@gmail.com |
| Dr Shaswat Verma |
Ramaiah Memorial Hospital |
Department of Physiotherapy, 3rd floor, New BEL Road, M S Ramaiah Nagar, MSRIT Post, Bangalore
Bangalore
KARNATAKA |
7338413544
sahanashankar19101999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee M S Ramaiah Medical College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J986||Disorders of diaphragm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL, as it is an observational study |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Mechanically ventilated patients, SIMV or CPAP
mode of ventilation
2. Alert and able to follow simple commands |
|
| ExclusionCriteria |
| Details |
1. Presence of flail chest or rib fracture
2. Arrhythmias and acute myocardial infarction
3. Unconsciousness patient
4. Neurological damage
5. Muscular dystrophy
6. Cognitive/psychiatric/intellectual impairment that impaired to follow commands |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Respiratory muscle strength in ventilated patients. |
The respiratory muscle strength will be assessed till the patient is extubated from ventilator support. The outcome will be assessed 4 weeks and 8 weeks apart |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of stay on the ventilator |
Length of stay on a ventilator is predicted till the patient is extubated. The outcome will be assessed after 4 weeks 8 weeks apart. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
13/11/2023 |
| 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 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
|
Muscle weakness commonly seen in the ICU is known as ICU-acquired weakness (ICU-AW). ICU-AW is detected in 30 to 50% of patients and the incidence is even higher (up to 67%) in critically ill patients with sepsis. The two most common types of muscle weakness associated with ICU stay are peripheral and respiratory muscle weakness. Respiratory muscle weakness is twice as prevalent as limb muscle weakness in ICU patients. Respiratory muscle weakness is associated with a higher risk of weaning failure, a longer duration of ventilator dependence and increases long-term morbidity and mortality. Respiratory muscle weakness is a common cause of weaning failure and is associated with prolonged mechanical ventilation (MV) and prolonged stay in intensive care units. Maximal inspiratory pressure (MIP) is a helpful tool for evaluating inspiratory muscle strength and can be determined by using the end-expiratory occlusion technique. Respiratory muscle strength values can serve as the baseline data for the physiotherapist to develop intervention protocols based on muscle strength that may help improve patient outcomes and decrease health care costs. Therefore, the need arises to measure respiratory muscle strength in ventilated patients. Assessment of Respiratory muscle strength will be done by Maximal Inspiratory Pressure(MIP). This will be done by asking the patient to make inspiratory efforts and hold for 20 seconds. A drop in maximum negative pressure during expiratory hold will be noted. Maximal respiratory pressure is then calculated by the difference between the total PEEP and the maximal negative pressure drop. MIP will be calculated based on the following formula: MIP=TOTAL PEEP – MAXIMAL NEGATIVE PRESSURE. Follow-up for the measurement of respiratory muscle strength will be done till the patient is extubated. |