| CTRI Number |
CTRI/2023/08/056669 [Registered on: 21/08/2023] Trial Registered Prospectively |
| Last Modified On: |
20/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between work done by ventilator and number of days on mechanical ventilation in ICU patients with respiratory failure |
|
Scientific Title of Study
|
Correlation of Mechanical power to duration of mechanical ventilation in patients with respiratory failure-A prospective observational 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 |
RajeshKannan Varadharajan |
| Designation |
Senior resident |
| Affiliation |
St.John s Medical college |
| Address |
Department of Critical care,
St.John Medical College,
John Nagar, Koramangala,
Bengaluru, Karnataka-560034
Bangalore KARNATAKA 560034 India |
| Phone |
8968189986 |
| Fax |
|
| Email |
phoenixrkan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Carol D silva |
| Designation |
Associate professor |
| Affiliation |
St.John medical college |
| Address |
Department of Critical care,
St.John medical college,
John nagar, Koramangala,
Bengaluru, Karnataka-560034
Bangalore KARNATAKA 560034 India |
| Phone |
9766397569 |
| Fax |
|
| Email |
carol.ds@stjohns.in |
|
Details of Contact Person Public Query
|
| Name |
RajeshKannan Varadharajan |
| Designation |
Senior resident |
| Affiliation |
St.John s Medical college |
| Address |
DEepartment of critical care,
St.John medical college,
John nagar, Koramangala,
Bengaluru, Karnataka-560034
Bangalore KARNATAKA 560034 India |
| Phone |
8968189986 |
| Fax |
|
| Email |
phoenixrkan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Critical care, St.John Medical College,
John nagar, Koramangala,
Bengaluru,
Karnataka-560034 |
|
|
Primary Sponsor
|
| Name |
RajeshKannan Varadharajan |
| Address |
Department of critical care,
St.John Medical college,
John Nagar, Koramangala,
Bengaluru,
Karnataka-560034 |
| 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 |
| RajeshKannan Varadharajan |
Medical ICU of St.John Medical College |
Department of Critical Care,
St.John Medical college,
John Nagar, Koramangala,
Bengaluru,
Karnataka-560034
Bangalore KARNATAKA |
8968189986
phoenixrkan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns Medical college Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (3) ICD-10 Condition: G00-G99||Diseases of the nervous system, (4) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (5) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (6) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (7) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (8) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (9) ICD-10 Condition: K00-K95||Diseases of the digestive system, (10) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age more than 18 years
Patients who require mechanical ventilation for atleast 48 hours for respiratory failure
Patients who have been sedated and paralysed at the time of evaluation in the first 24 hours |
|
| ExclusionCriteria |
| Details |
Patients with obstructive airway diseases and in respiratory acidosis.
Patients requiring obligatory hyperventilation due to raised intracranial pressure of severe metabolic acidosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the mechanical power of ventilation on day 1 of ICU admission and determine itss correlation with the duration of mechanical ventilation |
Day 1 of ICU admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To determine the correlation of mechanical power of ventilation on day 1 of ICU admission with the length of ICU stay/mortality.
2)Correlation of mechanical power with lung aeration score
3)Occurrence of Ventilator Induced Lung Injury-i)Barotrauma-Pneumothorax, Pneumomediastinum
ii)New onset worsening of oxygenation & radiological deterioration without an inciting cause. |
Till end of ICU stay/Death |
|
|
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)
|
30/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/08/2023 |
| 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 - NO
|
|
Brief Summary
|
All
patients admitted in St John’s Medical College Hospital ICU who are intubated
and mechanically ventilated will be assessed for inclusion in the study within
the first 24 hours of initiation of mechanical ventilation. For Consenting
patients, Identification number and basic details - demographics will be
entered in the Proforma. Comorbidities, reason for intubation, hemodynamic
parameters will be noted.
All evaluations of ventilatory
parameters and Ultrasound based evaluations shall be performed by principal
investigator under supervision.
• For
patients who have been intubated, sedated and paralysed, on volume controlled
ventilation the following parameters shall be noted down – respiratory rate
(breaths/min) set, tidal volume (ml) set, minute volume set, PEEP (cm H2O) levels
set and the inspiratory expiratory ratio set.
• Peak
pressure(PIP), plateau pressure (by applying inspiratory hold for 3-5 seconds),
mean airway pressure, Total positive end expiratory pressure- PEEP ( by
applying expiratory hold for 3 seconds) and hence auto PEEP, driving pressure (
plateau pressure – PEEP), (all in units of cm H2O) dynamic compliance
(Vt/PIP-PEEP), static compliance (Vt/Plateau-PEEP), resistance will also be noted down.
•
Mechanical power
will be calculated according to the following equation as per the comprehensive
equation for mechanical ventilation defined by gattinoni et al.
MP=0.098
* RR * Vt * [ PIP -0.5(Pplat-PEEP)]
·
Lung ultrasound
will be done with a curved array transducer of 2-5MHz as per blue protocol and
a composite lung aeration score will be calculated. This score is
computed in six regions per hemithorax: anterior, lateral, and posterior fields
are identified by sternum, anterior, and posterior axillary lines; each field
is divided into superior and inferior regions
|
Score
|
Lung findings
|
aeration
|
|
0
|
A-lines or ≤ 2 B-lines
|
normal
|
|
1
|
≥ 3 or more well spaced B-lines
|
Moderate loss
|
|
2
|
Coalescent B-lines
|
Severe loss
|
|
3
|
Tissue – like pattern
|
Complete loss
|
|