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CTRI Number  CTRI/2023/06/053973 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 15/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational analytical study 
Study Design  Other 
Public Title of Study   Can artificial intelligence using machine algorithm help in preventing fall in blood pressure in seriously ill patients 
Scientific Title of Study   Comparison of hypotensive events in critically ill patients managed with or without machine learning algorithm 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yugansh Gupta 
Designation  Post Graduate Resident 
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001, India

Central
DELHI
110001
India 
Phone    
Fax    
Email  yug.sagittarius@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maitree Pandey 
Designation  Director Professor and HOD of Department of Anaesthesia 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anaesthesia, Main academic building, Room No.502, Lady Hardinge Medical College, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001, India

Central
DELHI
110001
India 
Phone    
Fax    
Email  maitreepandey@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maitree Pandey 
Designation  Director Professor and HOD of Department of Anaesthesia 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anaesthesia, Main academic building, Room No.502 Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001, India

Central
DELHI
110001
India 
Phone    
Fax    
Email  maitreepandey@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Lady Hardinge Medical College and Associated Hospitals 
 
Primary Sponsor  
Name  Lady Hardinge Medical College and Associated Hospitals 
Address  Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India 
Type of Sponsor  Government medical college 
 
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 
Dr Yugansh Gupta  Lady Hardinge Medical College and Associated Hospitals  Main Intensive Care Unit, Department of Anaesthesia, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001, India
Central
DELHI 
8860697084

yug.sagittarius@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: C00-D49||Neoplasms, (3) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, (4) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (5) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (6) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (7) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (8) ICD-10 Condition: K00-K95||Diseases of the digestive system, (9) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (10) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (11) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (12) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (13) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (14) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.More than 18years old
2.Critically ill patients admitted to intensive care with an arterial catheter in the radial artery for advanced hemodynamic monitoring
 
 
ExclusionCriteria 
Details  1.Patients having sustained hypotension despite receiving maximum drug support
2.Patients admitted to intensive care with hypertensive emergencies
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison between median (IQR) number of hypotensive events in critically ill patients being managed with or without machine learning algorithm  48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Sensitivity, specificity, positive predictive value, negative predictive value of HPI & HPI threshold predicting hypotension using AUROC  48 hours 
Mean/ median time to MAP less than 65 mmHg after HPI ≥ 85   48 hours 
Comparison between groups of average duration (min) of each hypotensive event  48 hours 
Comparison between groups of percentage agreement between decision taken by the clinician to that suggested by the machine learning algorithm   48 hours 
Comparison between groups of proportion of patients with morbidity within 3 days of first event of hypotension (number of patients with acute kidney injury, increased troponin levels)  72 hours 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   26/06/2023 
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="1"
Months="4"
Days="19" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Study will be conducted after the approval from the institutional ethical committee and will be registered with clinical trials registry of India (CTRI). Patients being managed with advanced haemodynamic monitoring and other inclusion criteria will be recruited for the study. A written and informed voluntary consent for inclusion in the study will be obtained from the patient or next of kin, after carefully explaining the procedure, its benefits and risks in vernacular. A detailed history and physical examination will be carried out.

Patient characteristics including age, gender, body weight and height will be noted. A note shall also be made of the diagnosis and vasoactive drugs being administered if any. The need for advanced haemodynamic monitoring by FloTrac sensor (without machine learning algorithm- Group I) or HPI (Acumen IQ sensor; machine learning algorithm- Group II) shall be decided by the consultant in charge of ICU, and only the events of hypotensive episodes, haemodynamic parameters and treatment instituted will be noted without any active intervention as part of the study.

The sensor is connected to the radial artery catheter of all the patients and placed at the level of right atrium before pressure equilibration (zeroing). The adequacy of the dynamic response of the pressure sensor is tested with the fast-flush test. In case of overdamping, the arterial line is tested for clots by flushing the system, and in case of intractable overdamping, a new line is placed to the other side as standard protocol. The sensor measures arterial blood pressure and derives advanced hemodynamic parameters from the arterial waveform every 20secs, advanced haemodynamic parameters such as SVV, PPV, Eadyn, CO, CI, SV, SVI, SVR and SVRI is available with FloTrac sensor and HPI with Acumen IQ sensor and displayed on the HemoSphere monitor.

Patients connected to FloTrac sensor receive treatment once hypotension (MAP<65 mmHg) has occurred and it is treated on the basis of the decision of the treating clinician based on the haemodynamic parameters.

In patients monitored by Acumen IQ sensor, if HPI is ≥85, despite MAP ≥65 mmHg, treatment to prevent hypotension is performed at the discretion of the treating clinician based on parameters of the HemoSphere monitor (SVV, PPV, Eadyn, CI, SVI or SVRI) viz, fluids, vasopressors, inotropes or a combination of these if required.

A note shall be made of the treatment instituted by the clinician in response to hypotension in the control group or HPI ≥85. Treatment performed shall be entered in both the groups. Furthermore, at the time of a hypotensive event, other parameters like PPV, SVV, Eadyn, SV, SVI, CO, CI, SVR and SVRI shall also be noted. An increase in PPV, SVV and Eadyn indicates hypovolemia and a need of fluids, a decrease in SVR and SVRI denotes decrease in resistance and hence need for vasopressors whereas, a decrease in SV, CO or CI indicates decreased cardiac contractility and need for inotropes or a combination of these, as a possible aetiology and management of hypotension.

The haemodynamic measurements will be recorded in the monitor for maximum of 48 hours after recruitment in the study or till the HemoSphere monitor is disconnected (whichever is earlier). Data will then be downloaded and number of hypotensive episodes along with its duration and time to MAP <65 mmHg after HPI ≥ 85 will be noted in both the groups. Morbidity will be defined in terms of end organ damage: AKI stage I or worsening as defined by KDIGO criteria (Annexure Ⅳ) within the first three days after the first episode of hypotension or an increase in plasma neutrophil gelatinase-associated lipocalin (pNGAL) levels of ≥ 100 (ng/ml) and myocardial dysfunction indicated by an increase in Troponin T levels of ≥ 0.003 (ng/ml) obtained every day for three days shall also be noted. Hypotension shall be defined as mean arterial pressure (MAP) of less than 65 mmHg.

Similar to the analysis by Wijenberge et al, to assess the performance of the algorithm a forward analysis, with a HPI threshold value of 85 will be used. If, within a 1 min window, the HPI is ≥85, we will consider this as an alarm. From the start of this alarm, hypotension (<65 mmHg) will be checked for over the next 20 min window of MAP. That means that any HPI value is ≥85 for more than 1 min and a MAP <65 mmHg will be considered a positive prediction. The time between the alarm and the onset of hypotension will be noted. If the HPI does not rise above 85, we will consider this as negative prediction. A true positive, false positive, true negative or false negative prediction will be counted as every 20 min timeframe.

To make sure that each alarm and each hypotensive event will be counted only once in the analysis, the window will be shifted forward 20 min in time following a true positive, false positive or a false negative detection. The data with an increase in MAP of ≥ 5 mmHg within 20 s or an increase in MAP of ≥ 8 mmHg within 2 min, starting from a baseline MAP < 70 mmHg will most likely be due to clinical treatment, hence such measurements will not be taken.

If the hypotension persists for more than 20 minutes despite fluid resuscitation and increase in vasopressors (noradrenaline >20µg/min or two vasopressors), it would be labelled as refractory and further HPI values shall not be noted till the MAP increases to >65 mmHg. However, it would be included for the final analysis.

 
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