Lymphatic Function During Mechanical Ventilation

Lymphatic Insufficiency Clinical Trial

— LYMPH-UP  

Official title:

Effect of Mechanical Ventilation on Peripheral Lymphatic Function - do Elevated Intrathoracic Pressure Impact Lymphatic Flow?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770752
• Other study ID #: P-2022-462
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: Lene Thorup, MD
• Phone: +4535457845
• Email: lene.thorup.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphatic Insufficiency

Intervention

Procedure:
• Elevated pressure ventilation
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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral lymphatic velocity (centimeters/second)	Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.	3 hours
Primary	Peripheral lymphatic frequency (contractions/minute)	Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.	3 hours