Saturation ExposureMättnad2017NCT03192930
Inflammatory and Cerebrospinal Biochemical Markers in Blood During Prolonged Hyperbaric Exposure
An observational study of Saturation Exposure and Decompression Injury, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Research hypothesis Prolonged hyperbaric exposure will affect the central nervous system Prolonged hyperbaric exposure will induce inflammatory changes Prolonged hyperbaric exposure will affect fluid regulation in the body Objectives: To investigate the presence of cerebrospinal biochemical markers in blood during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Saturation Exposure, Decompression Injury
- What is being tested?
- Hyperbaric exposure
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- 17 Mar 2017to 17 Jan 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Submariners and divers employed by the Swedish navy and individuals approved by the Swedish navy for work in a hyperbaric environment participating in the Swedish navy saturation diving tests. Submariners and divers employed by the Swedish navy and individuals approved by the Swedish navy for work in a hyperbaric environment not participating in the Swedish navy saturation diving tests.
Who may be able to join
- Submariners and divers employed by the Swedish navy or individuals approved by the Swedish navy for work in a hyperbaric Environment.
- Subjects in the intervention group must be participating in the Swedish navy saturation diving tests.
Who cannot join
- As this is a highly selected population there is no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatoriska Och Neurokemiska förändringar Vid ökat Omgivningstryck
Research hypothesis
- Prolonged hyperbaric exposure will affect the central nervous system
- Prolonged hyperbaric exposure will induce inflammatory changes
- Prolonged hyperbaric exposure will affect fluid regulation in the body
Read more
Objectives:
- To investigate the presence of cerebrospinal biochemical markers in blood during prolonged hyperbaric exposure
- To investigate changes in the quantity of cerebrospinal biochemical markers in blood during decompression after prolonged hyperbaric exposure
- To investigate the presence of inflammatory markers in blood during prolonged hyperbaric exposure
- To investigate changes in the quantity of inflammatory markers in blood during decompression after prolonged hyperbaric exposure
- To investigate if prolonged hyperbaric exposure alters fluid balance in the body
Read the detailed description
When diving with compressed air, a continuous accumulation of nitrogen will take place in the body. The total uptake of nitrogen by the tissues is dependent on the duration and depth of the performed dive. During prolonged exposure to hyperbaric conditions the body eventually will become saturated with nitrogen. In a hyperbaric environment corresponding to a depth of 30 meters seawater, nitrogen saturation could be expected after about 24 hours. Decompression can cause accumulated nitrogen to form intravascular bubbles.
It has long been considered that decompression sickness (DCS) is caused by bubble formation when dissolved nitrogen at the end of diving comes out of solution. Doppler ultrasound techniques have shown that intravascular gas bubbles could exist even after uneventful dives. Therefore, additional pathophysiological factors must be sought.
Dehydration is a common finding after diving in water. It is probably caused by a combination of a non-existent water intake during diving and a physiologically increased urine production, caused by the increased ambient pressure.
There is evidence of an increased inflammatory activity in blood after diving. Signs of neutrophil activation is a common finding. It is not known if hyperbaric exposure in itself is enough to elicit these biochemical changes or if the presence of intravascular nitrogen bubbles is needed.
Studies have shown that biochemical markers of central nervous system (CNS) injury can be detected in blood samples obtained from patients with DCS, metabolic and neurologic disease, during cardiac surgery and after traumatic brain injuries. Such markers can also be seen in blood after sport activities like boxing and breath hold diving. If biochemical markers of CNS injury will be present in blood after hyperbaric exposure is not known.
Diving is a common activity in society. It is practised both recreationally and professionally. The police, coast guard, emergency services and armed forces employ professional divers.
The Swedish armed forces (SwAF) Diving and Naval Medicine Center (DNC) is responsible for education and training of divers for SwAF. The centre is also responsible for research and development and conduct tests for diving medicine, and tests of underwater equipment.
SwAF DNC will during 2017 perform saturation diving tests in a dry chamber environment. The study "Inflammatory and cerebrospinal biochemical markers in blood during prolonged hyperbaric exposure - an observational controlled study" will be followed out during these tests. It entails venous blood sampling, spirometric testing and cardiac ultrasound.
This is a prospective, controlled observational study. The study aims to involve at least 16 study subjects. Half of the subjects (at least 8 persons), named the intervention group, will be exposed to hyperbaric conditions. The hyperbaric exposure is part of the Swedish navy saturation diving tests. Half of the subjects (at least 8 persons), named the control group, will experience no hyperbaric exposure.
The intervention group will be compressed in a dry hyperbaric chamber to 4 ATA and remain at that pressure for 36 hours. They will then be decompressed 0,5 meters/hour for 30 hours, after which they will be decompressed 0,375 meters/hour for 40 hours. After 70 hours of decompression normal atmospheric pressure will be reached and the subjects will leave the hyperbaric chamber. The oxygen partial pressure inside the chamber will be actively controlled and never exceed 50 kPa.
Members of the intervention group will be examined by a physician trained in diving medicine before and after the hyperbaric exposure. Spirometric testing of lung function will be carried out at both these occasions. Immmediately after hyperbaric exposure cardiac ultrasound will be used to assess presence and duration of VGE.
Five blood samples (6 mL blood each) will be obtained from all study subjects from both groups according to the following plan:
- before compression commences
- about one hour before decompression commences
- within one hour after leaving the hyperbaric chamber
- about 24 hours after leaving the hyperbaric chamber
- if possible, about 5-7 days after leaving the hyperbaric chamber.
Blood samples are obtained from the control group at the same time points as from the intervention group.
In addition to above mentioned samples, blood samples (6 mL blood each) regarding fluid balance will be obtained from intervention group subjects before, during and after hyperbaric exposure.
Signs of DCS will be actively sought.
- Conditions
- Saturation Exposure, Decompression Injury
- Being tested
- Hyperbaric exposure
- Keywords
- Hyperbaric, Saturation, Decompression injury, Decompression sickness, Inflammation, Central nervous system injury, Diving medicine
- Medical subject headings
- Decompression Sickness, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric exposureOther
Hyperbaric exposure 4 ATA for 36 hours followed by 70 hours decompression
| Study group | Role | What they receive |
|---|---|---|
| Saturation | Individuals exposed to prolonged hyperbaric exposure Receives: Other: Hyperbaric exposure | |
| Control | Individuals not exposed to prolonged hyperbaric exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of inflammatory and cerebrospinal biochemical markers in blood
- g: tau, NfL, GFAP, UCHL-1, VCAM-1, ICAM-1, Endothemin-1 and others
Measured: 14 days
Secondary outcomes (4)
Biochemical signs of altered fluid balance in the body
Hematocrit
Measured: 7 days
Changes in lung function
Spirometry (FVC, FEV, diffusing capacity)
Measured: 7 days
Presence of Venous gas Emboli (VGE)
Doppler and 2-D echocardiography
Measured: 7 days
Decompression sickness (DCS)
Clinical diagnosis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start17 Mar 2017
- Primary completion17 Jan 2018
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Saturation ExposureStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Armed Forces Diving and Naval Medicine Centre, KTH Royal Institute of Technology
- Responsible party
- Principal investigator, Anders Rosén, Sahlgrenska University Hospital
- Investigators
- Henrik Zetterberg, PhD, Study director, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192930
- Sponsor's protocol ID
- EPN 022-17
- Acronym
- Mättnad2017
- Status last verified
- Mar 2018
- First submitted
- 14 Jun 2017
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosen A, Gennser M, Oscarsson N, Kvarnstrom A, Sandstrom G, Blennow K, Seeman-Lodding H, Zetterberg H. Biomarkers of neuronal damage in saturation diving-a controlled observational study. Eur J Appl Physiol. 2020 Dec;120(12):2773-2784. doi: 10.1007/s00421-020-04499-y. Epub 2020 Sep 25.
PubMed 32975632
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatoriska Och Neurokemiska förändringar Vid ökat Omgivningstryck
- ClinicalTrials.gov ID
- NCT03192930
- Acronym / sponsor ID
- Mättnad2017 / EPN 022-17
- Conditions
- Saturation Exposure, Decompression Injury
- Keywords
- Hyperbaric, Saturation, Decompression injury, Decompression sickness, Inflammation, Central nervous system injury, Diving medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Swedish Armed Forces Diving and Naval Medicine Centre, KTH Royal Institute of Technology
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 20 Jun 2017 (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.
Research hypothesis
- Prolonged hyperbaric exposure will affect the central nervous system
- Prolonged hyperbaric exposure will induce inflammatory changes
- Prolonged hyperbaric exposure will affect fluid regulation in the body
Objectives:
- To investigate the presence of cerebrospinal biochemical markers in blood during prolonged hyperbaric exposure
- To investigate changes in the quantity of cerebrospinal biochemical markers in blood during decompression after prolonged hyperbaric exposure
- To investigate the presence of inflammatory markers in blood during prolonged hyperbaric exposure
- To investigate changes in the quantity of inflammatory markers in blood during decompression after prolonged hyperbaric exposure
- To investigate if prolonged hyperbaric exposure alters fluid balance in the body
Detailed description
When diving with compressed air, a continuous accumulation of nitrogen will take place in the body. The total uptake of nitrogen by the tissues is dependent on the duration and depth of the performed dive. During prolonged exposure to hyperbaric conditions the body eventually will become saturated with nitrogen. In a hyperbaric environment corresponding to a depth of 30 meters seawater, nitrogen saturation could be expected after about 24 hours. Decompression can cause accumulated nitrogen to form intravascular bubbles.
It has long been considered that decompression sickness (DCS) is caused by bubble formation when dissolved nitrogen at the end of diving comes out of solution. Doppler ultrasound techniques have shown that intravascular gas bubbles could exist even after uneventful dives. Therefore, additional pathophysiological factors must be sought.
Dehydration is a common finding after diving in water. It is probably caused by a combination of a non-existent water intake during diving and a physiologically increased urine production, caused by the increased ambient pressure.
There is evidence of an increased inflammatory activity in blood after diving. Signs of neutrophil activation is a common finding. It is not known if hyperbaric exposure in itself is enough to elicit these biochemical changes or if the presence of intravascular nitrogen bubbles is needed.
Studies have shown that biochemical markers of central nervous system (CNS) injury can be detected in blood samples obtained from patients with DCS, metabolic and neurologic disease, during cardiac surgery and after traumatic brain injuries. Such markers can also be seen in blood after sport activities like boxing and breath hold diving. If biochemical markers of CNS injury will be present in blood after hyperbaric exposure is not known.
Diving is a common activity in society. It is practised both recreationally and professionally. The police, coast guard, emergency services and armed forces employ professional divers.
The Swedish armed forces (SwAF) Diving and Naval Medicine Center (DNC) is responsible for education and training of divers for SwAF. The centre is also responsible for research and development and conduct tests for diving medicine, and tests of underwater equipment.
SwAF DNC will during 2017 perform saturation diving tests in a dry chamber environment. The study "Inflammatory and cerebrospinal biochemical markers in blood during prolonged hyperbaric exposure - an observational controlled study" will be followed out during these tests. It entails venous blood sampling, spirometric testing and cardiac ultrasound.
This is a prospective, controlled observational study. The study aims to involve at least 16 study subjects. Half of the subjects (at least 8 persons), named the intervention group, will be exposed to hyperbaric conditions. The hyperbaric exposure is part of the Swedish navy saturation diving tests. Half of the subjects (at least 8 persons), named the control group, will experience no hyperbaric exposure.
The intervention group will be compressed in a dry hyperbaric chamber to 4 ATA and remain at that pressure for 36 hours. They will then be decompressed 0,5 meters/hour for 30 hours, after which they will be decompressed 0,375 meters/hour for 40 hours. After 70 hours of decompression normal atmospheric pressure will be reached and the subjects will leave the hyperbaric chamber. The oxygen partial pressure inside the chamber will be actively controlled and never exceed 50 kPa.
Members of the intervention group will be examined by a physician trained in diving medicine before and after the hyperbaric exposure. Spirometric testing of lung function will be carried out at both these occasions. Immmediately after hyperbaric exposure cardiac ultrasound will be used to assess presence and duration of VGE.
Five blood samples (6 mL blood each) will be obtained from all study subjects from both groups according to the following plan:
- before compression commences
- about one hour before decompression commences
- within one hour after leaving the hyperbaric chamber
- about 24 hours after leaving the hyperbaric chamber
- if possible, about 5-7 days after leaving the hyperbaric chamber.
Blood samples are obtained from the control group at the same time points as from the intervention group.
In addition to above mentioned samples, blood samples (6 mL blood each) regarding fluid balance will be obtained from intervention group subjects before, during and after hyperbaric exposure.
Signs of DCS will be actively sought.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saturation | – | Other: Hyperbaric exposureIndividuals exposed to prolonged hyperbaric exposure |
| Control | – | –Individuals not exposed to prolonged hyperbaric exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Submariners and divers employed by the Swedish navy and individuals approved by the Swedish navy for work in a hyperbaric environment participating in the Swedish navy saturation diving tests. Submariners and divers employed by the Swedish navy and individuals approved by the Swedish navy for work in a hyperbaric environment not participating in the Swedish navy saturation diving tests.
Key inclusion criteria (2 listed)
- Submariners and divers employed by the Swedish navy or individuals approved by the Swedish navy for work in a hyperbaric Environment.
- Subjects in the intervention group must be participating in the Swedish navy saturation diving tests.
Key exclusion criteria (1 listed)
- As this is a highly selected population there is no exclusion criteria.
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 exposureHyperbaric exposure 4 ATA for 36 hours followed by 70 hours decompression | Other | Saturation |
Primary outcome
Concentration of inflammatory and cerebrospinal biochemical markers in blood
Time frame: 14 days
E. g: tau, NfL, GFAP, UCHL-1, VCAM-1, ICAM-1, Endothemin-1 and others
4 secondary outcomes
Biochemical signs of altered fluid balance in the body
Time frame: 7 days
Changes in lung function
Time frame: 7 days
Presence of Venous gas Emboli (VGE)
Time frame: 7 days
Decompression sickness (DCS)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 32975632Rosen A, Gennser M, Oscarsson N, Kvarnstrom A, Sandstrom G, Blennow K, Seeman-Lodding H, Zetterberg H. Biomarkers of neuronal damage in saturation diving-a controlled observational study. Eur J Appl Physiol. 2020 Dec;120(12):2773-2784. doi: 10.1007/s00421-020-04499-y. Epub 2020 Sep 25.
- 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.
Henrik Zetterberg, PhD study director
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Saturation Exposure and Decompression Injury, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 9 Apr 2019. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of inflammatory and cerebrospinal biochemical markers in blood (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03192930, which also lists 1 linked publication.
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 9 Apr 2019.