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

NCT03431402 | Unknown DMC

• 1 other identifier: KasrELAiniH critical care dep.
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• Hospital mortality

  2 years

• Hospital length of stay

  2 years

Study Arms (2)

Acute stroke receive hyperbaric oxygen

OTHER

Drug: Hyperbaric oxygen

Acute stroke receive only conventional treatment

NO INTERVENTION

Interventions

Hyperbaric oxygen 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 hyperbaric oxygen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with acute ischemic stroke
• Glasgow coma scale more than 10

You may not qualify if:

• Patient with cerebral hemorrhage
• Patient received thrombolytic therapy
• Emphysema with carbon dioxide (CO2) retention
• Pneumothorax
• Seizure disorder

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Ibrahim Shehata Hussin

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Ibrahim Shehata, MSC

CONTACT

001011946001; shehata772@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of critical care medicine

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 13, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)