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.
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.
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
- 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%.
- Setting: Medico-surgical intensive care unit of a university hospital
- Design: Pilot prospective, observational study
- Procedures:
- 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.
- 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.
- Endpoints: Diagnostic accuracy of the PVi (AUROC) for correctly classifying HFNC patients who would respond to fluid challenge (ΔCO >15%).
- 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.
- Conditions
- Respiratory Insufficiency, Shock, Septic, Sepsis
- 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 group | Role | What they receive |
|---|---|---|
| HFNC + hypoperfusion + Responders | Patients 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-Responders | Same 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.
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.
- First posted28 Jan 2019
- Study start1 Jan 2017
- Primary completion30 Mar 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oriol Roca, MD PhD, Principal investigator, Hospital Vall d'Hebron
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PletHysmographic Variation InDex to pRedict Fluid Responsiveness in Spontaneously breAThing patiEnts Treated With High Flow Nasal Cannula
- ClinicalTrials.gov ID
- NCT03817996
- Acronym / sponsor ID
- HIDRATE / PR(AG)409/2016
- Conditions
- Respiratory Insufficiency, Shock, Septic, Sepsis
- Keywords
- High flow nasal cannula, Nasal high flow, Plethysmographic variation index, Fluid responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2017
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 28 Jan 2019 (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.
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.
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
- 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%.
- Setting: Medico-surgical intensive care unit of a university hospital
- Design: Pilot prospective, observational study
- Procedures:
- 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.
- 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.
- Endpoints: Diagnostic accuracy of the PVi (AUROC) for correctly classifying HFNC patients who would respond to fluid challenge (ΔCO >15%).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC + hypoperfusion + Responders | – | Other: Fluid challengePatients 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. |
| HFNC + hypoperfusion + Non-Responders | – | –Same as previous but their CO do not increase >15% after passive leg raising maneuver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with HFNC presenting with any sign of hypoprefusion.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Cardiac arrhythmia
- Known intracardiac shunt
- Severe valvular heart disease
- Severe hypoxemia (PaO2/FIO2 <60 mmHg)
- Left ventricular ejection fraction of <50%
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 |
|---|---|---|
| Fluid challenge250ml of saline in Responders (those who increased >10% their cardiac output after a passive leg raising maneuver). | Other | HFNC + hypoperfusion + Responders |
Primary outcome
Best cutoff value of the PVi to identify fluid responsiveness
Time frame: 30 minutes
Best cutoff value of the PVi (defined by the Youden method) for correctly classifying HFNC patients who would respond to fluid challenge (ΔCO >10%).
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 13 Aug 2019.
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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.
Oriol Roca, MD PhD principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
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.