LYMPH-UP: Lymphatic Function During Mechanical Ventilation

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05770752
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphatic Insufficiency	Procedure: Elevated pressure ventilation	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effect of Mechanical Ventilation on Peripheral Lymphatic Function - do Elevated Intrathoracic Pressure Impact Lymphatic Flow?
• Actual Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Outcome Measures

Primary Outcome Measures

1. Peripheral lymphatic velocity (centimeters/second) [3 hours]

   Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.

2. Peripheral lymphatic frequency (contractions/minute) [3 hours]

   Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Copenhagen University Hospital	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lene Thorup, Principal Investigator, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT05770752
• Other Study ID Numbers: P-2022-462
• First Posted: Mar 15, 2023
• Last Update Posted: Mar 15, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 15, 2023