Lymphatic Function During Mechanical Ventilation (LYMPH-UP)

November 17, 2023 updated by: Lene Thorup, Rigshospitalet, Denmark

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergoing surgery for jaw malformations
  • Age > 18 years
  • Informed consent
  • Cardiopulmonary healthy

Exclusion Criteria:

  • History of Cardiac disease
  • History of pulmonary disease
  • History of lymphatic disease
  • Peripheral edema
  • Chronic infectious disease
  • Age > 30 years
  • BMI > 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral lymphatic velocity (centimeters/second)
Time Frame: 3 hours
Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.
3 hours
Peripheral lymphatic frequency (contractions/minute)
Time Frame: 3 hours
Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Lene Thorup, MD, Copenhagen University Hospital at Herlev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • P-2022-462

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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