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Completed

NCT Number: NCT05201755

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

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.

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Key information

Conditions

Ventilation Therapy; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Ca' Granda - Ospedale Policlinico Maggiore

Milan, 20122, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1 or 2
  • BMI > 20

Exclusion criteria

  • History of pneumothorax
  • History of venous thrombosis

Treatment and study plan

CPAP

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.

Primary outcomes

  1. Venous diameter

    Time frame: 15 minutes

    Changes in diameter of the basilica vein (mm) in subjects breathing at room air or breathing at 10 cmH2O of positive end expiratory pressure

Secondary outcomes

  1. Flow-velocity

    Time frame: 15 min

    Changes in venous flow-velocity of the basilica vein (cm/sec) in subjects breathing at room air or breathing at 10 cmH2O of positive end-expiratory pressure

  2. Venous diameter

    Time frame: 15 min

    Changes in venous diameter (mm) in subjects breathing with a CPAP helmet fastened with the straps under the armpits or with the CPAP helmet tied to the bed instead.

  3. Flow-velocity

    Time frame: 15 min

    Changes in venous flow-velocity (cm/sec) in subjects breathing with a CPAP helmet fastened with the straps under the armpits or with the CPAP helmet tied to the bed instead.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

Continuous Positive Airway Pressure (CPAP) Influence on the Evaluation of Basilica Vein Diameter for Catheter Implantation.

Acronym: PEEPVEIN-2021

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2022
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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