Lymphatic Function During Mechanical Ventilation

NCT ID: NCT05770752

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-10-31

Brief Summary

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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

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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

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Lymphatic Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Lene Thorup

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lene Thorup, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital at Herlev

Locations

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Copenhagen University Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lene Thorup, MD

Role: CONTACT

+4535457845

Facility Contacts

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Lene Thorup

Role: primary

+4535457845

Other Identifiers

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P-2022-462

Identifier Type: -

Identifier Source: org_study_id

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