Ultrasound Measurements of Basilica Vein Diameter at Room Air Breathing and at Positive Pressure on Healthy Volunteers

NCT ID: NCT05201755

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-03-31

Brief Summary

Peripherally Inserted Central Catheters (PICC) and midline placement requires the catheter size to be one third of the venous diameter, or less. However, measurements during CPAP (Continous Positive Airway Pressure) might overestimate the diameter of veins in patients requiring a PICC line.

The investigators will enroll 28 healthy subjects to measure their basilica vein diameter at atmospheric pressure and at 10 cmH2O of Positive End-Expiratory Pressure (PEEP). PEEP will be applied through a CPAP helmet with the straps placed under the arms or tied to the bed.

The investigators will test the hypothesis that positive airway pressure significantly increases vein diameter. Under this hypothesis, the indication of avoiding catheters larger than one third of the vein diameter should be revised, as venous enlargement during PEEP may lead to the placement of inappropriately large catheters.

Detailed Description

After consent, the investigators will enroll 28 participants, randomized with a 1:1:1:1 ratio (sealed envelope) to one of the following groups:

A) Room air -> CPAP (armpit straps) -> CPAP (w/o straps) B) Room air -> CPAP (w/o straps) -> CPAP (armpit straps) C) CPAP (armpit straps) -> CPAP (w/o straps) -> Room air D) CPAP (w/o straps) -> CPAP (armpit straps) - > Room air

The investigators will exclude from the study participants with an ASA score (American Society of Anesthesiology) of 3 or more, subjects with a BMI lower than 20 or with a history of pneumothorax or venous thrombosis. Investigators will enroll adult patients only (age > 18).

The primary endpoint is the evaluation of a clinically significant change in venous diameter in subjects breathing at room air or during positive pressure support.

The investigators decided to deliver CPAP through a CPAP Helmet, as this device is noninvasive, very weill tolerated and widely used at the study hospital. CPAP Helmet are provided with armpit straps. Secondary endpoints are the evaluation of venous flow-velocity changes and the influence of placing the helmet straps under the armpits on venous flow dynamics (venous diameter, flow-velocity).

The study is composed of three steps of 5 minutes each. At each step, the investigators will use ultrasound to measure the diameter of basilica vein and venous flow-velocity at the right mid arm, while recording basic vital signs (heart rate, non-invasive blood pressure, pulsoximetry). The investigators will also gather basic biometric data (age, weight, height, gender). At room air, no intervention is given: after 5 minutes, vital signs are collected and the ultrasound measurements performed (basilica vein diameter, venous blood flow-velocity). At CPAP (armpit straps), the subjects will wear a CPAP helmet and receive 10 cmH2O of PEEP (positive end-expiratory pressure), with the helmet straps placed under the subjects' armpit: after 5 minutes, vital signs are collected and the ultrasound measurements performed (basilica vein diameter, venous blood flow-velocity). At CPAP (w/o straps), the helmet is tied to the subjects' bed: after 5 minutes, vital signs are collected and the ultrasound measurements performed (basilica vein diameter, venous blood flow-velocity).

Conditions

Ventilation Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A

Investigators will evaluate the diameter of the basilica vein and venous flow-velocity after 5 minutes of breathing at room air. Investigators will collect basic vital parameters (heart rate, blood pressure, pulsoximetry).

Afterwards, the investigators will administer CPAP through a helmet, with the straps placed under the armpits. After 5 minutes, the investigators will collect again ultrasound data (venous diameter of basilica vein, flow-velocity) and basic vital parameters (heart rate, blood pressure, pulsoximetry).

Then the CPAP helmet will be tied to the bed and the armpit straps removed. After 5 minutes the investigators will collect ultrasound data and basic vital parameters as in the steps before (venous diameter, flow-velocity, heart rate, blood pressure, pulsoximetry). After this three steps, the protocol ends.

Group Type: OTHER

CPAP

Intervention Type: DEVICE

Application of PEEP (positive end-expiratory pressure) through a CPAP Helmet with a set PEEP of 10 cmH2O. It is a very well tolerated and noninvasive device commonly used for ventilatory support.

B

Same interventions and measurements as A, in different order (breathing room air, then with a CPAP helmet tied to the bed, then with a CPAP helmet fastened with armpit straps).

Group Type: OTHER

CPAP

Intervention Type: DEVICE

Application of PEEP (positive end-expiratory pressure) through a CPAP Helmet with a set PEEP of 10 cmH2O. It is a very well tolerated and noninvasive device commonly used for ventilatory support.

C

Same interventions and measurements as A, in different order (breathing with a CPAP fastened with armpit straps, breathing with a CPAP helmet tied to the bed and breathing at room air).

Group Type: OTHER

CPAP

Intervention Type: DEVICE

Application of PEEP (positive end-expiratory pressure) through a CPAP Helmet with a set PEEP of 10 cmH2O. It is a very well tolerated and noninvasive device commonly used for ventilatory support.

D

Same interventions and measurements as A, in different order (breathing with a CPAP helmet tied to the bed, breathing with a CPAP helmet fastened with armpit straps and breathing at room air).

Group Type: OTHER

CPAP

Intervention Type: DEVICE

Application of PEEP (positive end-expiratory pressure) through a CPAP Helmet with a set PEEP of 10 cmH2O. It is a very well tolerated and noninvasive device commonly used for ventilatory support.

Interventions

CPAP

Application of PEEP (positive end-expiratory pressure) through a CPAP Helmet with a set PEEP of 10 cmH2O. It is a very well tolerated and noninvasive device commonly used for ventilatory support.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ASA 1 or 2
• BMI > 20

Exclusion Criteria

• History of pneumothorax
• History of venous thrombosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Massimiliano Pirrone

Medical Doctor, Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimiliano Pirrone, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

IRCCS Fondazione Ca' Granda - Ospedale Policlinico Maggiore

Milan, , Italy

Countries

Italy

Other Identifiers

Not assigned

Identifier Type: -

Identifier Source: org_study_id