Ventilated Patient in Intensive CarePEEPUSNCT02569424
Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins
A study testing Patient's position in people with Ventilated Patient in Intensive Care and Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilated Patient in Intensive Care, Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position
- What is being tested?
- Patient's position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Dec 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient ventilated in intensive care is eligible.
- Age ≥ 18 years
- Patient with stable hemodynamic status and Mean Blood Pressure (< 65 mmHg)
- Patient with registered social security number
Who cannot join
- clinical sign for a central venous thrombosis (unilateral edema ...).during echography screening before inclusion
- presence of a central line for more than 48 hours.
- Anechoic patient (checked during echography screening)
- History of cervical spine surgery.
- IntraCranial HyperTension
- patient in shock with hemodynamic instability and not stabilized
Show all 9Show fewer
- patient treated by noradrenaline > 1 µg/kg/min
- patient or relative's refusal
- protected patients ≥ 18 years, minors, pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins: A Cross-over Randomized Controlled Study
There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins.
In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.
The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.
Read the detailed description
There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins.
In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.
The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.
- Conditions
- Ventilated Patient in Intensive Care, Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position
- Being tested
- Patient's position
- Keywords
- PEEP level, Trendelenburg position, cross-sectional area of the jugular and subclavian veins, central venous catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient's positionBehavioural
Supine or Trendelenburg strict -20°)
| Study group | Role | What they receive |
|---|---|---|
| ventilated patients | Experimental | Patient's position (Supine or Trendelenburg strict -20°) Receives: Behavioral: Patient's position |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cross-sectional area of the jugular veins ( in cm2)
The cross-sectional area of the jugular veins ( in cm2) at the end of the intervention
Measured: at baseline
Secondary outcomes (5)
The cross-sectional area of the subclavian veins ( in cm2)
The cross-sectional area of the subclavian veins ( in cm2) at the end of the intervention
Measured: at baseline
The antero-posterior diameter of the jugular veins (in mm)
The antero-posterior diameter of the jugular veins (in mm) at the end of the intervention
Measured: at baseline
The antero-posterior diameter of the subclavian veins (in mm)
The antero-posterior diameter of the subclavian veins (in mm) at the end of the intervention
Measured: at baseline
The distance between posterior and pleural lining of the jugular veins (in mm)
The distance between posterior and pleural lining of the jugular veins (in mm) at the end of the intervention
Measured: at baseline
The distance between posterior and pleural lining of the subclavian veins (in mm)
The distance between posterior and pleural lining of the subclavian veins (in mm) at the end of the intervention
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilated Patient in Intensive CareStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569424
- Sponsor's protocol ID
- CHU-0246
- Other IDs
- 2015-A00606-43
- Acronym
- PEEPUS
- Status last verified
- Dec 2016
- First submitted
- 24 Sep 2015
- Last updated
- 5 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins: A Cross-over Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02569424
- Acronym / sponsor ID
- PEEPUS / CHU-0246
- Conditions
- Ventilated Patient in Intensive Care, Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position
- Keywords
- PEEP level, Trendelenburg position, cross-sectional area of the jugular and subclavian veins, central venous catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Oct 2015 (estimated)
- 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.
There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins.
In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.
The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.
Detailed description
There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins.
In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.
The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilated patients | Experimental | Behavioral: Patient's positionPatient's position (Supine or Trendelenburg strict -20°) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient ventilated in intensive care is eligible.
- Age ≥ 18 years
- Patient with stable hemodynamic status and Mean Blood Pressure (< 65 mmHg)
- Patient with registered social security number
Key exclusion criteria (9 listed)
- clinical sign for a central venous thrombosis (unilateral edema ...).during echography screening before inclusion
- presence of a central line for more than 48 hours.
- Anechoic patient (checked during echography screening)
- History of cervical spine surgery.
- IntraCranial HyperTension
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 |
|---|---|---|
| Patient's positionSupine or Trendelenburg strict -20°) | Behavioural | ventilated patients |
Primary outcome
The cross-sectional area of the jugular veins ( in cm2)
Time frame: at baseline
The cross-sectional area of the jugular veins ( in cm2) at the end of the intervention
5 secondary outcomes
The cross-sectional area of the subclavian veins ( in cm2)
Time frame: at baseline
The antero-posterior diameter of the jugular veins (in mm)
Time frame: at baseline
The antero-posterior diameter of the subclavian veins (in mm)
Time frame: at baseline
The distance between posterior and pleural lining of the jugular veins (in mm)
Time frame: at baseline
The distance between posterior and pleural lining of the subclavian veins (in mm)
Time frame: at baseline
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 5 Dec 2016.
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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.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient's position in people with Ventilated Patient in Intensive Care and Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 4 inclusion and 9 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 5 Dec 2016. 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 France. 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?
The cross-sectional area of the jugular veins ( in cm2) (time frame: at baseline). 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 5 Dec 2016.