Head Position in Acute Stroke Trial

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/03/006738
• Date of registration: 17-03-2016
• Prospective Registration: No
• Primary sponsor: National Health and Medical Research Council of Australia
• Public title: Head Position in Acute Stroke Trial
• Scientific title: An investigator-initiated and conducted, international, multicentre, cluster, randomised cross-overcontrolled trial to establish the comparative effectiveness of different head positioning in patients with acute stroke - HEADPoST
• Date of first enrolment: 24-09-2015
• Target sample size: 19500
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12006
• Study type: Interventional
• Study design: Cluster Randomized Trial; Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Australia, Brazil, Chile, China, India, Sri Lanka, Taiwan, United Kingdom, United States of America

Contacts

• Name: Jeyaraj Durai Pandian
• Affiliation: Christian Medical College, Ludhiana

• Name: Jeyaraj Durai Pandian
• Affiliation: Christian Medical College, Ludhiana

Key inclusion & exclusion criteria

Inclusion criteria: • are adults aged greater than or equal to 18 years(the age for adults may vary in different countries)

• have a presumed clinical diagnosis of acute stroke (i.e. with a persistent neurological deficit on presentation),

• present to hospital, or have an in-hospital event or transfer from another hospital, with acute stroke.


Exclusion criteria: • transient ischaemic attack (TIA) (i.e. symptoms have resolved upon presentation),

• definite clinical contraindication or indication to either the sitting up or lying flat head positions,

• significant medical condition that takes priority in care and where adherence to the randomised head position is not possible on another ward/department of the hospital,

• immediate transfer from the ED or admission, to another ward for medical treatment (e.g. for haemodialysis) or surgery (e.g. carotid endarterectomy, haematoma evacuation) where adherence to the randomised head position is not possible.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- All acute stroke patients admitted to the hospital

Intervention(s)

Intervention1: The lying flat (0°) head position for one cluster group followed by the sitting-up (greater than or equal to 30°) head position: The lying flat (0°) head position: the intervention is for all patients to be nursed lying flat (0°) immediately after diagnosis of acute stroke is made and to remain in this position for 24 hours. These patients are to have strict bed rest for the first 24 hours after admission to hospital and should be toileted in bed.Feeding may commence after they have passed an appropriate swallowing screen or assessment; it is possible for patients to eat on their side in the flat position as swallow is an active process that is not dependent on gravity.
The sitting-up (greater than or equal to 30°) head position â?? the intervention is for all patients to be nursed with their head elevated (greater than or equal to 30°) by raising the head of the bed (or with extra pillows or wedge) immediately after the diagnosis of acute stroke is made, and to remain in this position for the first 24 hours after admission to hospital. They may be nursed on their side, while the head position remains at greater than or equal to 30°.Gentle mobilization is also allowed for this group. Feeding may commence after they have passed an appropriate swallowing test.
Control Intervention1: NO Comparator: NIL

Primary Outcome(s)

primary outcome will be a shift (improvement) in death and disability according to the patientâ??s modified Rankin Score (mRS) at 90 days.Timepoint: 90 days

Secondary Outcome(s)

1. Death or dependency measured by a shift in NIHSS(46) at 7 days

2. Death within 90 days

3. Length of hospital stay

4. the European Quality of Life Scale 5 Dimension (EQ-5D)

5. Pneumonia according to standard criteria involving a set combination of symptomatology and radiological signs

Timepoint: 1. Death or dependency at 7 days

2. Death within 90 days

3. Pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission

Secondary ID(s)

NIL

Source(s) of Monetary Support

National Health and Medical Council of Australia The George Institute for Global Health Level 10, King George V Building, Missenden Road, Camperdown, Sydney NSW 2050 Australia

Ethics review

Status: Approved
Approval date: 23/05/2015
Contact:

Institutional Ethics Committee, Christian Mediacl College and Hospital, Ludhaina

Status: Approved
Approval date: 20/10/2015
Contact:

Narayana Health Medical Ethics Committee

Status: Approved
Approval date: 23/11/2015
Contact:

Institutional Ethics Committee Dr. Ramesh Cardiac and Multidisciplinary Hospital P Limited

Status: Approved
Approval date: 14/01/2016
Contact:

Institutional Ethics Committee, Baby Memorial Hospital Limited

Status: Approved
Approval date: 15/02/2016
Contact:

Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology

Status: Approved
Approval date: 16/02/2016
Contact:

Institute Ethics Committee, All India Institute of Medical Sciences

Status: Approved
Approval date: 22/03/2016
Contact:

NIMHANS Ethics Committee

Status: Approved
Approval date: 30/03/2016
Contact:

Institutional Ethics Committee Post Graduate Institute of Medical Education and Research