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Clinical Trials/NCT05770752
NCT05770752
Recruiting
Not Applicable

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

Rigshospitalet, Denmark1 site in 1 country20 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphatic Insufficiency
Sponsor
Rigshospitalet, Denmark
Enrollment
20
Locations
1
Primary Endpoint
Peripheral lymphatic frequency (contractions/minute)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
October 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lene Thorup

Principal Investigator

Rigshospitalet, Denmark

Eligibility Criteria

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

Outcomes

Primary Outcomes

Peripheral lymphatic frequency (contractions/minute)

Time Frame: 3 hours

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

Peripheral lymphatic velocity (centimeters/second)

Time Frame: 3 hours

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

Study Sites (1)

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