Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke
Primary Purpose
Acute Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hyperbaric oxygen
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Stroke
Eligibility 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
Sites / Locations
- Ibrahim Shehata HussinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Acute stroke receive hyperbaric oxygen
Acute stroke receive only conventional treatment
Arm Description
Outcomes
Primary Outcome Measures
Change in national institute of health stroke score before and after treatment with hyperbaric oxygen therapy
The national institute of health stroke score (NIHSS) is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Maximum score of 42) "Mild" disease was defined as score of 0-14, "moderate" as 15-28, and "severe" as 29-42.
As pretreatment evaluation, all patients will be evaluated by national institute of health stroke score within 48 hours after admission.
As posttreatment evaluation, patients in the hyperbaric oxygen therapy group were evaluated by national institute of health stroke score after 10 sessions of hyperbaric oxygen therapy.
The control group was evaluated with national institute of health stroke score 10 days after stroke onset.
One month after treatment, all patients were evaluated again using the national institute of health stroke score.
Secondary Outcome Measures
Hospital mortality
Hospital length of stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03431402
Brief Title
Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke
Official Title
Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background and Rationale:
Cerebrovascular disease is always ranked at the top causes of death and most of hospitalized acute stroke patients have ischemic stroke [1].
Although the mortality rate of acute ischemic stroke is less than that of hemorrhagic stroke [1], it still results in patient disabilities and complications that often lead to significant costs to individuals, families, and society.
Traditional treatment for acute ischemic stroke includes thrombolytic therapy by injecting tissue plasminogen activator (t-PA) within three hours after onset of symptoms [2], antiplatelets and/or anticoagulant agents administered within the first 48 hours. Clinically, the narrow time window of thrombolytic therapy and coexisting contraindications limit the use of t-PA [2]. Thus, searching for an effective supplemental treatment for acute ischemic stroke is imperative.
Hyperbaric oxygen therapy (HBOT) is valuable in treating acute carbon monoxide poisoning [3,4], air or gas embolism [5], facilitating wound healing [6] and has been used as an adjuvant treatment for many neurological disorders that need further study as concussion [7] , stroke [8,9], cerebral palsy [ 10],traumatic brain injury [ 11], cerebral air embolism [12], Autism [13] and multiple sclerosis [14].
Indications of hyperbaric oxygen therapy recommended by undersea and hyperbaric medical society (UHMS) [15] are 1.air or gas embolism [5], 2.carbon monoxide poisoning [3,4], 3.clostridial myositis and myonecrosis [16], 4.crush injury, compartment syndrome and other acute traumatic ischemias [17], 5.decompression sickness [18], 6.arterial insufficiencies [19], 7.severe anemia [20], 8.intracranial abscess [21], 9.necrotizing soft tissue infections [22],10. refractory osteomyelitis [23], 11.delayed radiation injury [24], 12.compromised grafts and flaps [25], 13.acute thermal burn injury [26] and 14.idiopathic sudden sensorineural hearing loss [27].
Known mechanisms of HBOT-induced neuroprotection include enhancing neuronal viability via increased tissue oxygen delivery to the area of diminished blood flow, reducing brain edema, and improving metabolism after ischemia [28,29]. Furthermore, a recent study performed on a rat suggested that upregulation of the expression of glial derived neurotrophic factor (GDNF) and nerve growth factor (NGF) might underlie the effect of HBOT [30].
The effectiveness of use of Hyperbaric oxygen therapy in human ischemic stroke is still controversial that need further evaluation.
Detailed 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):
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acute stroke receive hyperbaric oxygen
Arm Type
Other
Arm Title
Acute stroke receive only conventional treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen
Intervention Description
- 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
Primary Outcome Measure Information:
Title
Change in national institute of health stroke score before and after treatment with hyperbaric oxygen therapy
Description
The national institute of health stroke score (NIHSS) is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Maximum score of 42) "Mild" disease was defined as score of 0-14, "moderate" as 15-28, and "severe" as 29-42.
As pretreatment evaluation, all patients will be evaluated by national institute of health stroke score within 48 hours after admission.
As posttreatment evaluation, patients in the hyperbaric oxygen therapy group were evaluated by national institute of health stroke score after 10 sessions of hyperbaric oxygen therapy.
The control group was evaluated with national institute of health stroke score 10 days after stroke onset.
One month after treatment, all patients were evaluated again using the national institute of health stroke score.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Hospital mortality
Time Frame
2 years
Title
Hospital length of stay
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Shehata, MSC
Phone
001011946001
Email
shehata772@gmail.com
Facility Information:
Facility Name
Ibrahim Shehata Hussin
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Shehata, MSC
Email
shehata772@gmail.com
First Name & Middle Initial & Last Name & Degree
Shereen Elgengeehy, MD
First Name & Middle Initial & Last Name & Degree
Tamer Fahmy, MD
First Name & Middle Initial & Last Name & Degree
Mahmoud Kenawi, MD
First Name & Middle Initial & Last Name & Degree
waleed Farouk, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke
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