The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating Stroke

NCT04376359 | Unknown

• 1 other identifier: 2018jyxm0772
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperbaric Oxygen Therapy; Stroke; Pneumonia

Keywords

Oral opportunistic pathogens; Pneumonia complicating stroke; Metagenome

Outcome Measures

Primary Outcomes (2)

• Incidence of pneumonia

  To calculate and compare the incidence of pneumonia between interventional group and control group, to identify whether the intervention approach could reduce the incidence.

  2 months

• Metagenomics

  To analyze and compare the effect of intervention on the diversity of bacteria in saliva samples and lower respiratory sputum samples.

  2 months

Secondary Outcomes (1)

• Short Form Health Survey 12 (SF-12)

  2 months

Study Arms (2)

hyperbaric oxygen therapy

EXPERIMENTAL

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.

Procedure: hyperbaric oxygen therapy

Control

NO INTERVENTION

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

Interventions

hyperbaric oxygen therapy 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.

hyperbaric oxygen therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A mild disability (Barthel Index \> 70)
• The swallowing function is normal
• Indwelling nasogastric feeding tube
• 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

Sponsors & Collaborators

• Ya Zhang: lead

Study Sites (1)

The Second People's Hospital of Hefei

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Stroke; Pneumonia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Yinliang Qi, M.B.B.S.

  The Second People's Hospital of Hefei

  STUDY DIRECTOR

Central Study Contacts

Yinliang Qi, M.B.B.S.

CONTACT

+8618955133681; qiyl@mail.ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 6, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)