Ventilation Therapy; ComplicationsPEEPVEIN-2021NCT05201755
Ultrasound Measurements of Basilica Vein Diameter at Room Air Breathing and at Positive Pressure on Healthy Volunteers
A study testing CPAP in people with Ventilation Therapy; Complications, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilation Therapy; Complications
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1 or 2
- BMI > 20
Who cannot join
- History of pneumothorax
- History of venous thrombosis
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Fondazione Ca' Granda - Ospedale Policlinico Maggiore
Milan, 20122
About this study
Official title: Continuous Positive Airway Pressure (CPAP) Influence on the Evaluation of Basilica Vein Diameter for Catheter Implantation.
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.
Read the 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:
- 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
- Being tested
- CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). Receives: 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). Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes
Secondary outcomes (3)
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
Measured: 15 min
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.
Measured: 15 min
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.
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Feb 2022
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional cross-over study.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano Pirrone, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Massimiliano Pirrone, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201755
- Sponsor's protocol ID
- Not assigned
- Acronym
- PEEPVEIN-2021
- Status last verified
- Aug 2022
- First submitted
- 9 Jan 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure (CPAP) Influence on the Evaluation of Basilica Vein Diameter for Catheter Implantation.
- ClinicalTrials.gov ID
- NCT05201755
- Acronym / sponsor ID
- PEEPVEIN-2021 / Not assigned
- Conditions
- Ventilation Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Interventional cross-over study.
| Arm | Type | Receives |
|---|---|---|
| A | Other | Device: CPAPInvestigators 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. |
| B | Other | Device: CPAPSame 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). |
| C | Other | Device: CPAPSame 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). |
| D | Other | Device: CPAPSame 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1 or 2
- BMI > 20
Key exclusion criteria (2 listed)
- History of pneumothorax
- History of venous thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPApplication 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. | Device | A, B, C, D |
Primary outcome
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
3 secondary outcomes
Flow-velocity
Time frame: 15 min
Venous diameter
Time frame: 15 min
Flow-velocity
Time frame: 15 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimiliano Pirrone, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Ventilation Therapy; Complications, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous diameter (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.