Hyperbaric Oxygen TherapyNCT04376359
The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating Stroke
A study testing hyperbaric oxygen therapy in people with Hyperbaric Oxygen Therapy and Stroke, run by Ya Zhang at 1 site in China.
Trial summary
To investigate the evidence for the integration of hyperbaric oxygen therapy (HBOT) as part of interdisciplinary stroke rehabilitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperbaric Oxygen Therapy, Stroke, Pneumonia
- What is being tested?
- hyperbaric oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- Jun 2021to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Have an inner ear disease
- Claustrophobia
- Communication barriers and inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- hyperbaric oxygen therapy
- Keywords
- Oral opportunistic pathogens, Pneumonia complicating stroke, Metagenome
- Medical subject headings
- Stroke, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: hyperbaric oxygen therapy |
| Control | No intervention | Stroke patients were not treated with HBOT except for the same routine treatment as the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Metagenomics
To analyze and compare the effect of intervention on the diversity of bacteria in saliva samples and lower respiratory sputum samples.
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study startJun 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbaric Oxygen TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ya Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ya Zhang, Anhui Medical University
- Investigators
- Yinliang Qi, M.B.B.S., Study director, The Second People's Hospital of Hefei
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376359
- Sponsor's protocol ID
- 2018jyxm0772
- Status last verified
- Jan 2021
- First submitted
- 3 May 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating
- ClinicalTrials.gov ID
- NCT04376359
- Acronym / sponsor ID
- 2018jyxm0772
- Conditions
- Hyperbaric Oxygen Therapy, Stroke, Pneumonia
- Keywords
- Oral opportunistic pathogens, Pneumonia complicating stroke, Metagenome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Ya ZhangUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen therapy | Experimental | Procedure: hyperbaric oxygen therapyPatients 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. |
| Control | No intervention | –Stroke patients were not treated with HBOT except for the same routine treatment as the experimental group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen therapyHyperbaric 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. | Procedure or surgery | hyperbaric oxygen therapy |
Primary outcome
Incidence of pneumonia
Time frame: 2 months
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
Time frame: 2 months
To analyze and compare the effect of intervention on the diversity of bacteria in saliva samples and lower respiratory sputum samples.
1 secondary outcome
Short Form Health Survey 12 (SF-12)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yinliang Qi, M.B.B.S. study director
The Second People's Hospital of Hefei
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen therapy in people with Hyperbaric Oxygen Therapy and Stroke, run by Ya Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yinliang Qi, M.B.B.S. (+8618955133681, qiyl@mail.ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pneumonia (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.