NCT03817996

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

August 13, 2019

Status Verified

November 1, 2018

Enrollment Period

2.2 years

First QC Date

November 12, 2018

Last Update Submit

August 9, 2019

Conditions

Respiratory InsufficiencyShock, SepticSepsis

Keywords

High flow nasal cannulaNasal high flowPlethysmographic variation indexFluid responsiveness

Outcome Measures

Primary Outcomes (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%).

    30 minutes

Study Arms (2)

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.

Other: Fluid challenge

HFNC + hypoperfusion + Non-Responders

Same as previous but their CO do not increase \>15% after passive leg raising maneuver.

Interventions

Fluid challengeOTHER

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

HFNC + hypoperfusion + Responders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated with HFNC presenting with any sign of hypoprefusion.

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Respiratory InsufficiencyShock, SepticSepsis

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Oriol Roca, MD PhD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2018

First Posted

January 28, 2019

Study Start

January 1, 2017

Primary Completion

March 30, 2019

Study Completion

April 30, 2019

Last Updated

August 13, 2019

Record last verified: 2018-11

Locations

ES(1)