The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating Stroke

NCT ID: NCT04376359

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-08-31

Brief Summary

To investigate the evidence for the integration of hyperbaric oxygen therapy (HBOT) as part of interdisciplinary stroke rehabilitation.

Detailed Description

Pneumonia complicating stroke is very difficult to manage and has a very poor prognosis, leading to a significantly higher risk of death. Oral opportunistic pathogens have been reported to be associated with the incidence of pneumonia among non-stroke immunocompromised subjects. Preliminary studies found that patients with stroke had higher carriage rates of oral opportunistic pathogens than healthy subjects. Therefore, investigators hypothesize that pneumonia complicating stroke is associated with oral opportunistic pathogens, and hyperbaric oxygen therapy may reduce the incidence of pneumonia complicating stroke by increasing the flow of saliva, which can affect the species and relative abundance of oral opportunistic pathogens. In order to prove this, investigators need to (1) firstly conduct a randomized controlled trial to confirm whether hyperbaric oxygen therapy is able to reduce the levels of plaque, and the incidence of pneumonia complicating stroke at clinical level; (2) secondly employ metagenomics analysis to compare oral rinse samples and respiratory samples, and to identify pneumonia-associated "oral opportunistic pathogens group"; (3) finally elucidate how hyperbaric oxygen therapy influences the species and relative abundance of oral opportunistic pathogens. This proposed study will provide evidence for the integration of hyperbaric oxygen therapy as part of interdisciplinary stroke rehabilitation.

Conditions

Hyperbaric Oxygen Therapy; Stroke; Pneumonia

Study Design

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

Study Groups

hyperbaric oxygen therapy

Patients with stroke will receive the hyperbaric oxygen therapy (HBOT) for 40 times, which were completed on 40 business days over a 2-month period and each session lasted 90 minutes at 100% oxygen concentration and 2 atmospheres.

Group Type: EXPERIMENTAL

hyperbaric oxygen therapy

Intervention Type: PROCEDURE

Hyperbaric oxygen therapy is the patient put in airtight oxygen tank, by increasing the air pressure in the environment (1.5 to 3.0) under atmospheric pressure, to give 100% oxygen, the patient treatment time is approximately 60 minutes to 120 minutes in this way, can achieve the purpose of greatly increase the oxygen partial pressure in the organization, so as to achieve reverse brain edema, reduce lipid peroxidation, inhibiting leukocyte hyperactivity, rebuild the blood brain barrier.

Control

Stroke patients were not treated with HBOT except for the same routine treatment as the experimental group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

hyperbaric oxygen therapy

Hyperbaric oxygen therapy is the patient put in airtight oxygen tank, by increasing the air pressure in the environment (1.5 to 3.0) under atmospheric pressure, to give 100% oxygen, the patient treatment time is approximately 60 minutes to 120 minutes in this way, can achieve the purpose of greatly increase the oxygen partial pressure in the organization, so as to achieve reverse brain edema, reduce lipid peroxidation, inhibiting leukocyte hyperactivity, rebuild the blood brain barrier.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• New stroke events within 1-3 months (confirmed by CT and MRI)
• Moderate to severe disability (Barthel Index < 70)
• The patient is conscious, breathing autonomously, not undergoing tracheotomy or tracheal intubation for ventilator-assisted respiration
• No concurrent lower respiratory infections and other lung diseases
• The condition is relatively stable
• Cognitive function is normal to moderately impaired (Mini-Physical State Exchange, MMSE score>18)
• The Gugging Swallowing Screen (GUSS) shows swallowing difficulties
• No systemic and local use of antibiotic-containing mouthwash

Exclusion Criteria

• A mild disability (Barthel Index > 70)
• The swallowing function is normal
• Indwelling nasogastric feeding tube
• The neurological status of the patient was significantly dynamically altered (significantly improved or worsened) in the short term prior to inclusion in the trial
• The patient had been treated with hyperbaric oxygen for other indications
• Had a chest condition and cannot withstand the pressure changes caused by hyperbaric oxygen therapy
• Have an inner ear disease
• Claustrophobia
• Communication barriers and inability to give informed consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ya Zhang

OTHER

Sponsor Role: lead

Responsible Party

Ya Zhang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yinliang Qi, M.B.B.S.

Role: STUDY_DIRECTOR

The Second People's Hospital of Hefei

Locations

The Second People's Hospital of Hefei

Hefei, Anhui, China

Countries

China

Central Contacts

Yinliang Qi, M.B.B.S.

Role: CONTACT

qiyl@mail.ustc.edu.cn

+8618955133681

Other Identifiers

2018jyxm0772

Identifier Type: -

Identifier Source: org_study_id