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Mechanically Ventilated PatientsNCT05588180

The Ratio Of Femoral Vein Diameter To Femoral Artery Diameter With Pulse Pressure Variation As A Diagnostic Tool

A study testing FVD/FAD ratio guided and PPV in people with Mechanically Ventilated Patients, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In assessing critically ill patients, an accurate assessment of a patient's volume status and whether they will respond to a fluid challenge with an increase in cardiac output is vital. 1 When hypovolemia is detected, volume expansion is utilized to enhance hemodynamics and restore normal blood pressure. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Mechanically Ventilated Patients
What is being tested?
FVD/FAD ratio guided and PPV
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
18 Oct 2022to 20 May 2023
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • patients on mechanical ventilation

Who cannot join

  • cardiac arrhythmias
  • previously known significant valvular disease or intracardiac shunt
  • air leakage through chest drains
  • increasing intraabdominal pressure
  • norepinephrine infusion as it decreases PPV and SVV
  • peripheral vascular diseases
  • ARDS

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University hospital

    Al Fayyum, Faiyum Governorate, 63514

Other trials in Egypt

About this study

Official title: Comparing The Ratio Of Femoral Vein Diameter To Femoral Artery Diameter With Pulse Pressure Variation As A Diagnostic Tool For Fluid Responsiveness In Mechanically Ventilated Patients; A Prospective Observational Study

In assessing critically ill patients, an accurate assessment of a patient's volume status and whether they will respond to a fluid challenge with an increase in cardiac output is vital. 1 When hypovolemia is detected, volume expansion is utilized to enhance hemodynamics and restore normal blood pressure. 2 Hemodynamic tests (right atrial pressure, pulmonary artery occlusion pressure, and cardiac output ) are used to assess preload in critically ill patients, although these indexes are not necessarily reliable predictors of fluid status. According to the Starling law, fluid administration is hypothesized to boost cardiac output by raising preload, which describes a positive relationship between cardiac muscle fiber length and contractility. However, the Starling curve hits a plateau beyond its ascending leg, and additional fluid administration can be hazardous, leading to right ventricular overload and pulmonary edema Invasive or noninvasive techniques can be used to determine blood volume status. Assessments such as central venous pressure (CVP) and mean pulmonary artery pressure (mPAP) are both invasive procedures. Various factors influence CVP (including thoracic, pericardial, abdominal pressures, etc.). CVP can be used as a fluid management indication, although It can be misused to estimate blood volume or mislead methods for treatment. Dynamic indices such as stroke volume variation (SVV) and pulse pressure variation (PPV) are superior to static indices for assessing volume status. However, these dynamic indices are unreliable when a patient is ventilated with low tidal volume, such as acute respiratory distress syndrome (ARDS); the tidal volume is insufficient to change intrathoracic pressure significantly. Ultrasound (US) evaluation of the inferior vena cava (IVC) may help determine fluid status.

Read the detailed description

The study will be conducted in intensive care units of Fayoum University Hospitals after approval of the local institutional ethics committee, and the local institutional review board will approve the study. The inclusion criteria will be as follows: patients on mechanical ventilation(MV), aged between 18 and 60 years with circulatory failure defined as mean arterial pressure (MAP) less than 65 mmHg or systolic arterial pressure less than 90mm Hg with signs of hypoperfusion (urinary flow < 0.5mL/kg/ min for > 2hr, tachycardia > 100 beats/min, or presence of skin mottling, and serum lactate more than 2 mmol/L) 17 and showing positive PLRT. The exclusion criteria: cardiac arrhythmias, previously known significant valvular disease or intracardiac shunt, air leakage through chest drains, increasing intraabdominal pressure, norepinephrine infusion as it decreases PPV and SVV, masking their ability for the detection of FR15

, peripheral vascular diseases, ARDS patients due to low tidal volume a, Contraindication for fluid administration as cardiogenic shock, acute pulmonary edema or LVEF% less than 50%. , renal patients with oliguria and volume overload including patients on hemodialysis or patients with acute anuric renal failure., patients with lower extremity artery/vein thrombosis, significant lower extremity artery plaque, lower extremity artery occlusion, inferior vena cava filter implantation, lower extremity varicose veins,

All patients fulfilling criteria will be monitored by (1) 6 leads ECG, (2) noninvasive BP, (3)urinary catheter for UOP, (4) pulse oximeter then divided into 2 groups, group (P) PPV guided group and group (F) FVD/FAD ratio guided

Randomization of patients to each of the treatment groups will be done by a statistician not involved in the study, using the website randomization.com. The allocation concealment will be done by contacting the statistician giving him the patient number, age, and sex to receive the patient allocation in a sealed envelop.

The envelope is to be received and opened after the informed consent is obtained Neither the participants, the study investigator, the attending clinicians, nor the data collector will be aware of groups allocation till the study end. The Consolidated Standards of Reporting Trials (CONSORT)recommendation will be followed. Group (P):(n=30), patients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor, ensuring that the respiratory changes in arterial pressure reflect only the effects of positive pressure ventilation. Modes of ventilation are selected to volume or pressure-controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be set to not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be set at 14 breaths/min. Positive end-expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitors at the base line then infusion of 4ml/kg /h of crystalloids will be infused till PPV will be less than 13%. 15

Group(F) : (n=30), FVD/FAD ratio guided; US probe will be used first to find the bifurcation position of the femoral artery, and then the probe will be retracted proximally. The visual field of the bifurcation will disappear until the probe enters the main branch of the femoral artery, and the femoral artery and vein could be observed simultaneously. Under normal conditions, pulsation indicates the femoral artery, and its companion is the femoral vein. The mean FVD and FAD will be measured then the FVD / FAD ratio will be calculated.

Being tested
FVD/FAD ratio guided, PPV
Keywords
mechanically ventilated patients, FVD / FAD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FVD/FAD ratio guidedProcedure or surgery

    Ultrasound-guided ratio

  • PPVProcedure or surgery

    PPV

Study groups in NCT05588180
Study groupRoleWhat they receive
Group (P)Active comparatorGroup (P) PPV guided group
Receives: Procedure: PPV
Group (F)Active comparatorGroup (F) FVD/FAD ratio guided
Receives: Procedure: FVD/FAD ratio guided

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MAP

    mean arterial blood pressure

    Measured: the first 48 hours postoperative

Secondary outcomes (2)
  1. the cutoff value of FVD/FAD reflecting FR

    the cutoff value of FVD/FAD reflecting FR

    Measured: the first 48 hours postoperative

  2. PPV

    pulse variation index

    Measured: the first 48 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start18 Oct 2022
  3. Primary completion15 May 2023
  4. Study completion20 May 2023

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Model description
group (F) FVD/FAD ratio guided
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05588180
Sponsor's protocol ID
M 600
Status last verified
May 2023
First submitted
18 Oct 2022
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share data

Publications

  • Kalantari K, Chang JN, Ronco C, Rosner MH. Assessment of intravascular volume status and volume responsiveness in critically ill patients. Kidney Int. 2013 Jun;83(6):1017-28. doi: 10.1038/ki.2012.424. Epub 2013 Jan 9.

    PubMed 23302716
  • Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.

    PubMed 27858374

Questions about this trial

What is this clinical trial studying?

A study testing FVD/FAD ratio guided and PPV in people with Mechanically Ventilated Patients, run by Fayoum University Hospital at 1 site in Egypt.

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 1 inclusion and 7 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 24 May 2023. 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 Egypt. 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?

MAP (time frame: the first 48 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05588180, which also lists 2 linked publications.

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 24 May 2023.

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