Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke
Keywords
Abstract
Description
Study Methods:
Study Population A 60 adult (aged >18 years) patients were included with a diagnosis of acute thromboembolic ischemic stroke within 48 hours after onset, according to clinical picture and imaging findings by brain computed tomography (CT) without evidence of hemorrhage, upon admission to the hospital and no patient received thrombolytic therapy.
Inclusion criteria:
Group one, HBOT group (n = 30): thirty adult patients with acute ischemic stroke will receive conventional medical treatment ( as antiplatelet but not thrombolytic therapy) with 10 sessions of adjunctive hyperbaric oxygen therapy (HBOT) within 3-5 days after the onset of stroke .
Compared with Group two, control group(n = 30): thirty adult patients with acute ischemic stroke will receive conventional medical treatment alone.
The baseline clinical characteristics were similar in both groups.
Exclusion criteria:
- Patient with cerebral hemorrhage
- Patient received thrombolytic therapy
- Emphysema with carbon dioxide retention
- Pneumothorax
- Seizure disorder
- Uncontrolled high fever
Demographic Characteristics:
Adults more than 18 years, Any gender. All patients upon admission to the hospital will provide:
Complete history taking:Age, Gender, Smoking, Alcohol consumption, Past history: diabetes mellitus , hypertension , Chronic obstructive pulmonary disease, Epilepsy or cardiovascular disease.
Neurological assessment use NIHSS score Blood tests:Complete blood count , Coagulation profile, Fasting blood sugar., Renal function test (Urea and creatinine).
CT brain
Chest x-ray :
Electrocardiogram (ECG):
Dates
Last Verified: | 02/28/2018 |
First Submitted: | 01/31/2018 |
Estimated Enrollment Submitted: | 02/09/2018 |
First Posted: | 02/12/2018 |
Last Update Submitted: | 03/12/2018 |
Last Update Posted: | 03/13/2018 |
Actual Study Start Date: | 02/28/2018 |
Estimated Primary Completion Date: | 02/29/2020 |
Estimated Study Completion Date: | 05/31/2020 |
Condition or disease
Intervention/treatment
Drug: Acute stroke receive hyperbaric oxygen
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Other: Acute stroke receive hyperbaric oxygen | Drug: Acute stroke receive hyperbaric oxygen - HBOT group will receive 10 sessions of HBOT at 2.0 Atmosphere absolute (ATA) for one hour in a hyperbaric chamber pressured with compressed air, whereby patients will breath 100% oxygen to 2 ATA started within 3-5days after the onset of stoke plus conventional therapy as antiplatelets therapy, correction of hypovolaemia , hypoxia and adequate nutrition |
No Intervention: Acute stroke receive only conventional treatment |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion criteria: - Adult patients with acute ischemic stroke - Glasgow coma scale more than 10 Exclusion criteria: - Patient with cerebral hemorrhage - Patient received thrombolytic therapy - Emphysema with carbon dioxide (CO2) retention - Pneumothorax - Seizure disorder |
Outcome
Primary Outcome Measures
1. Change in national institute of health stroke score before and after treatment with hyperbaric oxygen therapy [2 years]
Secondary Outcome Measures
1. Hospital mortality [2 years]
2. Hospital length of stay [2 years]