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CTRI Number  CTRI/2024/07/069946 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Other 
Public Title of Study   Evaluation of AIIMS ICU Rehabilitation (AIR) a home care intervention facilitating family-led discharge of chronic critically ill patients with a tracheostomy. A multicentric evaluation of a complex healthcare intervention. 
Scientific Title of Study   Effectiveness of the AIIMS ICU Rehabilitation (AIR) intervention package facilitating supported discharge and family-led home-based care of chronically ill patients with a tracheostomy: a multicentric mixed methods 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 Swagata Tripathy 
Designation  Professor and HOD 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anesthesia and Critical Care

Khordha
ORISSA
751019
India 
Phone  8763400534  
Fax    
Email  tripathyswagata@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swagata Tripathy 
Designation  Professor and HOD 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anesthesia and Critical Care

Khordha
ORISSA
751019
India 
Phone  8763400534  
Fax    
Email  tripathyswagata@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swagata Tripathy 
Designation  Professor and HOD 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anesthesia and Critical Care

Khordha
ORISSA
751019
India 
Phone  8763400534  
Fax    
Email  tripathyswagata@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Swagata Tripathy 
Address  Department of anesthesia And critical care, AIIMS Bhubaneswar, Odisha - 751019, India. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Swagata Tripathy  AIIMS Bhubaneswar  Department of Anesthesia & Critical Care, Room 406, Academic Block, Sijua, Patrapada
Khordha
ORISSA 
8763400534

tripathyswagata@gmail.com 
Dr Ishwar Chandra Behera  Institue of Medical Sciences (IMS) and SUM Hospital  Department of Neurosciences, K8, Kalinga Nagar Bhubaneswar, Odisha, India Pin Code – 751003
Khordha
ORISSA 
9439744318

ishwarchandrabehera@soa.ac.in 
Dr Narendra Kumar Das  Kalinga Institute of Medical Sciences  Department of Neurosurgery, KIMS, Kushabhadra Campus (KIIT Campus-5) Patia, Bhubaneswar Odisha, India – 751024
Khordha
ORISSA 
7327096159

narendrakdas@gmail.com 
Dr Alok Kumar Panigrahy  SUM Ultimate medicare  Department of Neurosurgery, K8 , KALINGA NAGAR, GHATIKIA, BHUBANESWAR, 751003, ODISHA
Khordha
ORISSA 
7678382555

alokpanigrahy86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
IMS & SUM  Approved 
Institutional Ethics Committee, AIIMS Bhubaneswar  Approved 
Institutional Ethics Committee, KIMS   Approved 
SUM Ultimate Medicare  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tracheostomy group post implementation of AIR intervention  Adult tracheotomized chronically ill patients who are declared expected fit to discharge by the primary clinician for a period of 4 months 
Comparator Agent  Tracheostomy group pre implementation   Adult tracheotomized patients who are declared expected fit to discharge by the primary clinician before the AIR intervention is implemented for a period of 4 months. There is another comparator group for the ITS design, which has non tracheostomised patients, to control for historical or cyclic confounders. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult tracheostomised patients in the neurosurgery ICU, expected to survive beyond and need tracheostomy for more than 2 weeks after declared ‘expected fit to discharge’ from the ICU by the treating physician/ surgeon and willingness to give written informed consent.
 
 
ExclusionCriteria 
Details  Pediatric patients and patients without an identified family carer willing for home care,
Patients needing greater organ support than manageable at home (home ventilation excluded)
Current participation in an interventional trial with conflicting therapies or primary outcomes
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time from the clinician agreeing that the patient can be managed at home to the actual time of patient discharge.
 
Sixteen time points (at weekly intervals) before and 16 time points after the intervention is implemented. Approximately 5 discharges at every time point. Approximately 160 patients over 10months. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Patient & Carer Reported Outcomes measured at 1-months
a. Health related QoL (EQ-5D-3L) of patients at hospital discharge & at 1 month
b. Carer Burden Scores of carers at hospital discharge & at 1 month post discharge
2. Measures of safety
a. Hospital device-associated infections, e.g., CAUTI, VAP, HAP in rate of events within group per unit time.
b. Clinical outcomes– Bed sore, Tracheostomy block, Clinical Deterioration, readmission & mortality (rate/ unit time).
3. Measures of process
a. Adherence to the intervention
i. % consented
ii. % Trained at least 3 sessions
iii. Number of sessions missed.
iv. Subjective & objective scores of carers confidence post training
v. % using mHealth app at least once spontaneously after home discharge
vi. % 1 week home visits completed
vii. Data entry (completion)
b. Clinical
 
Till 30 days after ready for step down/ discharge 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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   Phase 4 
Date of First Enrollment (India)   15/07/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Tracheostomy, a procedure to create an opening in front of the trachea when performed on critically ill patients in intensive care units (ICUs) decreases the duration of mechanical ventilation, incidence of nosocomial infections and length of ICU stay. Its use early during (1)neuro-ICU stayis associated with improved chances of early rehabilitation and discharge due to decreased secondary insults and hospital acquired morbidity.(1) However when there is a lack of out-of-hospital state- sponsored or low cost rehabilitation facilities for these chronically ill bed ridden patients, timely discharge from the ICU and hospital becomes a challenge.  These patients need higher intensity care at home, including care of the tracheostomy and indwelling catheters, home ventilation, nasogastric feeding, physiotherapy and general nursing care. Fear, stigma and unpreparedness among family members and healthcare workers of caring for a patient with ‘a hole in the neck’ prolongs ICU and hospital stay, increasing the very morbidities the tracheostomy sought to avoid. Cost of care to patient family (carer) and the health care system increases as resources cannot be offered to more deserving acutely ill patients.

To address this gap, in Eastern India, we have developed, and pilot tested the AIIMS ICU Rehabilitation Intervention. The intervention with its components of counselling, hands-on training and education, facilitated discharge and post discharge support aims to implement family led home rehabilitation of chronically critically ill tracheostomy patients. This trial is to implement the intervention in three centres and evaluate the implementation process and effectiveness of the AIR intervention for family led home discharge of chronically critically ill post ICU patients.

 
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