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

NCT05201755 | Completed

• 1 other identifier: Not assigned
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation Therapy; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Flow-velocity

  15 min

• Venous diameter

  15 min

• Flow-velocity

  15 min

Study Arms (4)

A

OTHER

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.

Device: CPAP

B

OTHER

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).

Device: CPAP

C

OTHER

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).

Device: CPAP

D

OTHER

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).

Device: CPAP

Interventions

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.

A; B; C; D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1 or 2
• BMI \> 20

You may not qualify if:

• History of pneumothorax
• History of venous thrombosis

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

IRCCS Fondazione Ca' Granda - Ospedale Policlinico Maggiore

Milan, 20122, Italy

Location

Study Officials

• Massimiliano Pirrone, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Anesthesiologist

Model Details: Interventional cross-over study.

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 21, 2022
• Study Start: February 1, 2022
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)