The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating Stroke

The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating

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

Study Overview

• Status: Unknown
• Conditions: Stroke; Pneumonia; Hyperbaric Oxygen Therapy
• Intervention / Treatment: Procedure: hyperbaric oxygen therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The Second People's Hospital of Hefei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: 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.
NO_INTERVENTION: Control; Stroke patients were not treated with HBOT except for the same routine treatment as the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form Health Survey 12 (SF-12)	The concise health status scale (SF-12) IS used to assess the systemic health-related quality of life in stroke patients. It covers eight different areas: general health (GH), physical functioning (PF), bodily pain (BP), role-physical (RP), mental health (MH), vitality (VT), social functioning (SF), role-emotional (RE). The SF-12 consists of 12 items, and each of them has its own physical component summary (PCS) and mental component summary (MCS) regression coefficients. The response to each item will be multiplied by its PCS regression coefficient and added together with the PCS constant to provide Physical Health summary scores (SF-12 PCS). Mental Health summary scores (SF-12 MCS) will be calculated likewise. The higher the score, the higher the quality of life.	2 months

Collaborators and Investigators

• Sponsor: Ya Zhang
• Investigators: Study Director: Yinliang Qi, M.B.B.S., The Second People's Hospital of Hefei

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 3, 2020
• First Posted (ACTUAL): May 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Metagenome; Oral opportunistic pathogens; Pneumonia complicating stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Stroke; Pneumonia
• Other Study ID Numbers: 2018jyxm0772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No