Hyperbaric Oxygen Therapy After Stroke - PILOT

Norwegian Underwater Intervention (NUI)

Status and phase: Withdrawn; Phase 2

Conditions: Cerebral Stroke

Treatments: Drug: Hyperbaric oxygen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04149379

305476

Details and patient eligibility

About

The goal of this pilot study is to establish more information about hyperbaric oxygen therapy for this group of patients, and give us more information of how to initiate the best possible main study. Can we find any indications that support the use of this therapy for patients suffering from chronic disability after cerebral infarction? Can we improve physical and cognitive function.

Full description

This is a pilot project including 6 patients for one session of 20 treatments of hyperbaric oxygen therapy. The objective is to establish knowledge of HBO for this group of patients in a Norwegian context, so that we can prepare for the main study afterwards, including about 60-70 patients. We need to know how to optimize the administrative and technical systems for the larger study. We want to collect feedback from the patients undergoing the pilot study. We want more information about the treatment table, if 20 treatments are enough, if 2,4 bar pressure is adequate. The treatment table is based on existing research, and is considered safe.

The patients are to be treated at table 14/90, at 2,4 Absolute atmospheres, and daly 90 minutes of oxygen inhalation (medical oxygen).

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inlcution criteria:

• No age restriction
• Suffered from ischemic stroke (cerebral infarction) 6-12 months before inclusion.
• Stable phase after standard rehabilitation
• Measurable physical function failure and / or reduced ADL function.
• Sufficient physical function / mobility to be able to move into / out of the pressure chamber with the help of only one person (Tender).

Patients to participate in the study must be physically, mentally and cognitively fit for pressure chamber treatment. They must be able to stand for their own help, move with support, and be able to follow instructions. This is ensured by discretionary assessment after observation and interview with the patient.

Exclusion criteria:

• Claustrophobia

• Psychosis, severe anxiety

• Inability to equalize pressure in the middle ear

• Severe COPD and asthma, pathological lung sounds

• Hypertension (Blood pressure > 140/90 mmHg)

• Pregnancy

• Hernia

• Earlier fractures, or suspected fractures in the face

• Ongoing chemotherapy

• Previous treatment with Bleomycin

• Aphasia that prevents necessary communication

• Cognitive failure that prevents necessary co-operation in the pressure chamber.

• Previous or current pneumothorax, other lung injury

• Increased risk of pneumothorax

  • Known or suspected injury to the chest
  • Marfan syndrome
  • Homocystinuria
  • Family history of pneumothorax
  • Chronic lung disease (COPD, Emphysema, Asthma eller cystic fibrosis)
  • Tuberculosis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Treatment group

Experimental group

Description:

One group of 6 patients undergoing 20 sessions of hyperbaric therapy at table 14/90.

Treatment:

Drug: Hyperbaric oxygen