Lymphatic InsufficiencyLYMPH-UPNCT05770752
Lymphatic Function During Mechanical Ventilation
A study testing Elevated pressure ventilation in people with Lymphatic Insufficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study wil examine the effect of altered intrathoracic pressure on lymphatic function, by investigating the lymphatic vessels in the lower limb during mechanical ventilation. The lymphatic function will be examined using Near-Infrared Fluorescence Imaging. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Insufficiency
- What is being tested?
- Elevated pressure ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to Oct 2024
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing surgery for jaw malformations
- Age > 18 years
- Informed consent
- Cardiopulmonary healthy
Who cannot join
- History of Cardiac disease
- History of pulmonary disease
- History of lymphatic disease
- Peripheral edema
- Chronic infectious disease
- Age > 30 years
- BMI > 30
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital
Copenhagen, 2100
Lene Thorup, +4535457845, lene.thorup.01@regionh.dk
About this study
Official title: Effect of Mechanical Ventilation on Peripheral Lymphatic Function - do Elevated Intrathoracic Pressure Impact Lymphatic Flow?
This study wil examine the effect of altered intrathoracic pressure on lymphatic function, by investigating the lymphatic vessels in the lower limb during mechanical ventilation.
The lymphatic function will be examined using Near-Infrared Fluorescence Imaging.
Read the detailed description
This study wil examine the effect of altered intrathoracic pressure on lymphatic function. This will be done by investigating peripheral lymphatic vessels on patients undergoing surgery for malformations of the jaw who are being mechanically ventilated.
Subjects will be examined on two occasions. One to establish baseline function, and one during surgery following a ventilation protocol with altered PIP and PEEP.
- Conditions
- Lymphatic Insufficiency
- Being tested
- Elevated pressure ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevated pressure ventilationProcedure or surgery
Elevated pressure ventilation is defined as a raise in PIP and PEEP by 10 cmH2O from each patients original pressure setting, although never higher than a PIP of 30 cmH2O.
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral lymphatic velocity (centimeters/second)
Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.
Measured: 3 hours
Peripheral lymphatic frequency (contractions/minute)
Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Feb 2023
- Primary completionMar 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Thorup, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lene Thorup, MD, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770752
- Sponsor's protocol ID
- P-2022-462
- Acronym
- LYMPH-UP
- Status last verified
- Nov 2023
- First submitted
- 25 Jan 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Ventilation on Peripheral Lymphatic Function - do Elevated Intrathoracic Pressure Impact Lymphatic Flow?
- ClinicalTrials.gov ID
- NCT05770752
- Acronym / sponsor ID
- LYMPH-UP / P-2022-462
- Conditions
- Lymphatic Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 15 Mar 2023 (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.
This study wil examine the effect of altered intrathoracic pressure on lymphatic function, by investigating the lymphatic vessels in the lower limb during mechanical ventilation.
The lymphatic function will be examined using Near-Infrared Fluorescence Imaging.
Detailed description
This study wil examine the effect of altered intrathoracic pressure on lymphatic function. This will be done by investigating peripheral lymphatic vessels on patients undergoing surgery for malformations of the jaw who are being mechanically ventilated.
Subjects will be examined on two occasions. One to establish baseline function, and one during surgery following a ventilation protocol with altered PIP and PEEP.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients undergoing surgery for jaw malformations
- Age > 18 years
- Informed consent
- Cardiopulmonary healthy
Key exclusion criteria (7 listed)
- History of Cardiac disease
- History of pulmonary disease
- History of lymphatic disease
- Peripheral edema
- Chronic infectious disease
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 |
|---|---|---|
| Elevated pressure ventilationElevated pressure ventilation is defined as a raise in PIP and PEEP by 10 cmH2O from each patients original pressure setting, although never higher than a PIP of 30 cmH2O. | Procedure or surgery | – |
Primary outcome
Peripheral lymphatic velocity (centimeters/second)
Time frame: 3 hours
Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.
Peripheral lymphatic frequency (contractions/minute)
Time frame: 3 hours
Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
Lene Thorup, MD principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevated pressure ventilation in people with Lymphatic Insufficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 7 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 18 Nov 2023. 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 Denmark. 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 Lene Thorup, MD (+4535457845, lene.thorup.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral lymphatic velocity (centimeters/second) (time frame: 3 hours). 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 18 Nov 2023.