Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke

NCT ID: NCT03431402

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-06-01

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):

Conditions

Acute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Acute stroke receive hyperbaric oxygen

Group Type: OTHER

Hyperbaric oxygen

Intervention Type: DRUG

\- 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

Acute stroke receive only conventional treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tamer Salah aldin Fahmy

Professor of critical care medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ibrahim Shehata Hussin

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ibrahim Shehata, MSC

Role: CONTACT

shehata772@gmail.com

001011946001

Facility Contacts

Ibrahim Shehata, MSC

Role: primary

shehata772@gmail.com

Other Identifiers

KasrELAiniH critical care dep.

Identifier Type: -

Identifier Source: org_study_id