The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating Stroke
Primary Purpose
Hyperbaric Oxygen Therapy, Stroke, Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hyperbaric oxygen therapy
Sponsored by
![Ya Zhang](https://trials-media.s3.amazonaws.com/orgs/ya-zhang.jpeg)
About this trial
This is an interventional treatment trial for Hyperbaric Oxygen Therapy focused on measuring Oral opportunistic pathogens, Pneumonia complicating stroke, Metagenome
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
Sites / Locations
- The Second People's Hospital of Hefei
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
hyperbaric oxygen therapy
Control
Arm Description
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.
Stroke patients were not treated with HBOT except for the same routine treatment as the experimental group.
Outcomes
Primary Outcome Measures
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.
Metagenomics
To analyze and compare the effect of intervention on the diversity of bacteria in saliva samples and lower respiratory sputum samples.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04376359
Brief Title
The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating Stroke
Official Title
The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ya Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbaric Oxygen Therapy, Stroke, Pneumonia
Keywords
Oral opportunistic pathogens, Pneumonia complicating stroke, Metagenome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hyperbaric oxygen therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Stroke patients were not treated with HBOT except for the same routine treatment as the experimental group.
Intervention Type
Procedure
Intervention Name(s)
hyperbaric oxygen therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of pneumonia
Description
To calculate and compare the incidence of pneumonia between interventional group and control group, to identify whether the intervention approach could reduce the incidence.
Time Frame
2 months
Title
Metagenomics
Description
To analyze and compare the effect of intervention on the diversity of bacteria in saliva samples and lower respiratory sputum samples.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Short Form Health Survey 12 (SF-12)
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yinliang Qi, M.B.B.S.
Phone
+8618955133681
Email
qiyl@mail.ustc.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yinliang Qi, M.B.B.S.
Organizational Affiliation
The Second People's Hospital of Hefei
Official's Role
Study Director
Facility Information:
Facility Name
The Second People's Hospital of Hefei
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating Stroke
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