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Respiratory InsufficiencyHIDRATENCT03817996

Fluid Responsiveness in HFNC Patients

An observational study of Respiratory Insufficiency and Shock, Septic, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

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

The plethysmographic variation index (PVi) is a measure of the respiratory-induced variations in the plethysmographic waveform. Interestingly, in mechanically ventilated patients and under certain conditions, PVi may reflect fluid responsiveness (FR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Insufficiency, Shock, Septic, Sepsis
What is being tested?
Fluid challenge
How many people
30 participants
Where
1 siteSpain
Study dates
1 Jan 2017to 30 Apr 2019
Phase
Observational
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

Study population: Patients treated with HFNC presenting with any sign of hypoprefusion.

Who may be able to join

  • Patients treated with HFNC presenting with circulatory insufficiency defined as the presence of any of the folling signs: 1) hypotension (systolic blood pressure <90 mm Hg or the need for norepinephrine), 2) oliguria (urine output <0.5 mL/kg/hr), and 3) cool, mottled extremities.

Who cannot join

  • Cardiac arrhythmia
  • Known intracardiac shunt
  • Severe valvular heart disease
  • Severe hypoxemia (PaO2/FIO2 <60 mmHg)
  • Left ventricular ejection fraction of <50%
  • Hemodynamic instability during the procedure (defined as the variation in heart rate or blood pressure of >10% over the 15-min period before starting the protocol) and those with variations in arterial pulse pressure <13%.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

Other trials in Spain

About this study

Official title: PletHysmographic Variation InDex to pRedict Fluid Responsiveness in Spontaneously breAThing patiEnts Treated With High Flow Nasal Cannula

The plethysmographic variation index (PVi) is a measure of the respiratory-induced variations in the plethysmographic waveform. Interestingly, in mechanically ventilated patients and under certain conditions, PVi may reflect fluid responsiveness (FR).

Patients treated with high flow nasal cannula (HFNC), which has been described as a useful supportive therapy in spontaneously breathing patients with respiratory failure, may present the same hemodynamic changes, measured by transthoracic echocardiography, as those patients who are mechanically ventilated (MV). The hypothesis of the present study is that the PVi may predict FR in HFNC patients and, therefore, the objective is to investigate whether the PVi can predict FR in patients treated with HFNC.

Read the detailed description

STUDY BACKGROUND The plethysmographic variation index (PVi) is a measure of the respiratory-induced variations in the plethysmographic waveform. Interestingly, in mechanically ventilated patients and under certain conditions, PVi may reflect fluid responsiveness (FR) (Loupec T Crit Care Med 2011; Sandroni C Intensive Care Med 2012).

High flow nasal cannula (HFNC) has been described as a useful supportive therapy in spontaneously breathing patients with respiratory failure (Roca Crit Care 2016), by increasing lung volume and generating a certain level of airway positive pressure. It has been shown that patients treated with HFNC may present the same hemodynamic changes, measured by transthoracic echocardiography, as those patients who are mechanically ventilated (MV) (Roca J Crit Care 2013). Therefore, PVi may also be useful in HFNC patients.

HYPOTHESIS AND OBJECTIVE As the hemodynamic changes associated with HFNC use are similar to those observed in MV patients, the hypothesis of the present study is that PVi may predict FR in HFNC patients.

The objective is to investigate whether the PVi can predict FR in patients treated with HFNC.

METHODS

  1. Subjects: Patients treated with HFNC presenting with circulatory insufficiency, in whom volume expansion was planned by the attending physician. Exclusion criteria included spontaneous respiratory activity, cardiac arrhythmia, known intracardiac shunt, severe hypoxemia (PaO2/FIO2 <60 mmHg), left ventricular ejection fraction of <50%, hemodynamic instability during the procedure (defined as the variation in heart rate or blood pressure of >10% over the 15-min period before starting the protocol) and those with variations in arterial pulse pressure <13%.
  2. Setting: Medico-surgical intensive care unit of a university hospital
  3. Design: Pilot prospective, observational study
  4. Procedures:
  5. At baseline, all patients will be in semirecumbent position with the head at an angle of 45 degrees. ii. Measurements of CO and PVI will be performed in duplicate, before and after a fluid challenge (8ml/kg of colloids in 10 minutes). iii. Cardiac output (CO) will be estimated by averaging three consecutive measures obtained with transthoracic echocardiography (Porter TR. Journal of the American Society of Echocardiography 2015). The PVi will be measured using Masimo SET® pulse oximetry technology. The PVi is an automatic measure of the dynamic change in the perfusion index (Pi) that occurs during the respiratory cycle. The perfusion index (Pi) is the ratio of nonpulsatile to pulsatile blood flow through the peripheral capillary bed. iv. The decision to administer fluid was based on the presence of at least one clinical sign of inadequate tissue perfusion. Clinical signs of inadequate tissue perfusion were suspected at the bedside by observing hypotension (systolic blood pressure <90 mm Hg or the need for norepinephrine), oliguria (urine output <0.5 mL/kg/hr), and cool, mottled extremities.
  6. Total flow delivered by HFNC and dosages of vasopressive drugs will be kept unchanged during the entire procedure. vi. The HFNC device (Optiflow™ system, MR850 heated humidified RT202 delivery tubing, and RT050/051 nasal cannula; Fisher \& Paykel Healthcare Ltd, Auckland, New Zealand) consists of a low resistance nasal cannula that can deliver up to 60L/min of totally conditioned (37ºC and 100% of relative humidity) gas admixture. It is initiated with a minimum flow of 40L/min and a fraction of inspired oxygen (FIO2) of 1. Then, FIO2 is set to maintain a pulse oximetry (SpO2) above 92% and flow rate is set according to the physician's judgment.
  7. Endpoints: Diagnostic accuracy of the PVi (AUROC) for correctly classifying HFNC patients who would respond to fluid challenge (ΔCO >15%).
  8. Data analysis: Changes in hemodynamic measurements induced by fluid challenge will be assessed by using the nonparametric Wilcoxon's rank sum test for paired data. Patients will be divided into two groups according to changes ΔCO after fluid challenge. Those presenting a ΔCO >15% will be considered as responders and the others as nonresponders. Hemodynamic measurements will be compared using the nonparametric Mann-Whitney test for unpaired data. To assess the accuracy of the PVi for correctly classifying patients who would respond to fluid challenge, receiver operating characteristic curves (ROC) will be performed and the area under the curves (AUROC) will be calculated. The optimal threshold of continuous variables will be chosen to maximize the sum of sensitivity and specificity. This is a pilot observational study that will involve 20 patients.
Being tested
Fluid challenge
Keywords
High flow nasal cannula, Nasal high flow, Plethysmographic variation index, Fluid responsiveness
Medical subject headings
Respiratory Insufficiency, Shock, Septic, Sepsis

What participants receive

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

  • Fluid challengeOther

    250ml of saline in Responders (those who increased >10% their cardiac output after a passive leg raising maneuver).

Study groups in NCT03817996
Study groupRoleWhat they receive
HFNC + hypoperfusion + RespondersPatients treated with HFNC presenting with any sign of hypoperfusion, in whom volume expansion was planned by the attending physician. Clinical signs of inadequate tissue perfusion were suspected at the bedside by observing hypotension (systolic blood pressure <90 mm Hg or the need for norepinephrine), oliguria (urine output <0.5 mL/kg/hr), and cool, mottled extremities. Their CO increases >15% after passive leg raising.
Receives: Other: Fluid challenge
HFNC + hypoperfusion + Non-RespondersSame as previous but their CO do not increase >15% after passive leg raising maneuver.

What is being measured

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

  1. Best cutoff value of the PVi to identify fluid responsiveness

    Best cutoff value of the PVi (defined by the Youden method) for correctly classifying HFNC patients who would respond to fluid challenge (ΔCO >10%).

    Measured: 30 minutes

Timeline

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

  1. First posted28 Jan 2019
  2. Study start1 Jan 2017
  3. Primary completion30 Mar 2019
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03817996
Sponsor's protocol ID
PR(AG)409/2016
Acronym
HIDRATE
Status last verified
Nov 2018
First submitted
12 Nov 2018
Last updated
13 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Insufficiency and Shock, Septic, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

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 6 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 13 Aug 2019. 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 Spain. 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?

Best cutoff value of the PVi to identify fluid responsiveness (time frame: 30 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 13 Aug 2019.

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