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

Ventilation Therapy; Complications Clinical Trial

— PEEPVEIN-2021  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201755
• Other study ID #: Not assigned
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2022
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA 1 or 2
• BMI > 20

Exclusion Criteria:

• History of pneumothorax
• History of venous thrombosis

Related Conditions & MeSH terms

• Ventilation Therapy; Complications

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Ca' Granda - Ospedale Policlinico Maggiore	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous diameter	Changes in diameter of the basilica vein (mm) in subjects breathing at room air or breathing at 10 cmH2O of positive end expiratory pressure	15 minutes
Secondary	Flow-velocity	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	15 min
Secondary	Venous diameter	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.	15 min
Secondary	Flow-velocity	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.	15 min