Perfusion index derived from a pulse oximeter to predict fluid responsiveness in patients with acute circulatory failure in the intensive care unit
| ISRCTN | ISRCTN53719438 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53719438 |
| Secondary identifying numbers | 03-2021 |
- Submission date
- 18/05/2021
- Registration date
- 20/05/2021
- Last edited
- 20/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
A circulatory collapse (also called acute circulatory failure) is defined as a general or specific failure of the circulation. Although the mechanisms, causes and clinical syndromes are different, the effect is the same — the circulatory system fails to maintain the supply of oxygen and other nutrients to the tissues and to remove the carbon dioxide and other metabolites from them.
The aim of the study is to evaluate a noninvasive device to assess which patient will benefit to treat shock with intravenous fluids.
Who can participate?
Adults over 18 years, with acute circulatory failure.
What does the study involve?
The study involves measurements of common vital signs and a change of position in the bed that will drain the blood from the legs simulating the administration of intravenous fluids. The study does not involve the administration of drugs or experimental interventions
What are the possible benefits and risks of participating?
None
Where is the study run from?
Hospital Angeles Tijuana (Mexico)
When is the study starting and how long is it expected to run for?
March 2021 to October 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Damián Gutiérrez-Zárate MD, dr.guzda@gmail.com
Contact information
Scientific
Paseo de los Héroes No 10999, Zona Urbana Río
Tijuana, Baja California
22010
Mexico
 ORCID ID |
0000-0001-9353-4754 |
|---|---|
| Phone | 6646351900 |
| dr.guzda@gmail.com |
Study information
| Study design | Prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Changes in the plethysmographic perfusion index to detect fluid responsiveness in spontaneously ventilated patients |
| Study objectives | Changes in perfusion index accurately detect fluid responsiveness using a passive leg raising test in spontaneously ventilated patients with acute circulatory failure. |
| Ethics approval(s) | Approved 03/26/2021, Ethics and Research Committee of Hospital Angeles Tijuana (Operadora de Hospitales Angeles SA de CV, Paseo de los Héroes No 10999, Zona Urbana Río, Tijuana, Mexico; no telephone number provided; drclementezuniga@gmail.com), ref: none |
| Health condition(s) or problem(s) studied | Patients with acute circulatory failure |
| Intervention | Baseline data will be collected from all patients in a semi-fowler position (head between 30-35°). Which include demographic characteristics and hemodynamic measurements (changes in perfusion index and velocity integral time by transthoracic echocardiography). Subsequently, the passive leg elevation raising maneuver will be performed. After 2 minutes, when the maneuver produces its maximum effect on CO, another set of hemodynamic measurements will be taken. Afterward, the patient is returned to the initial semifowler position and after hemodynamic stabilization (2 minutes), the third set of hemodynamic measurements will be performed. |
| Intervention type | Behavioural |
| Primary outcome measure | Perfusion index and velocity integral time will be measure at baseline (time 0), after a passive leg-raising maneuver (time 1), and semi-fowler position after 2 minutes (time 2). (The changes of the (perfusion index) PI and (velocity integral time) VTI will be represented in relative changes: [PI before the maneuver (time 0) - PI after the maneuver (time 1)] / PI before the maneuver (time 0) x 100 and, [VTI before the maneuver (time 0) - VTI after the maneuver (time 1)] / IVT before the maneuver (time 0) x 100 respectively. A passive leg-raising maneuver will be defined as positive when an increase in VTI greater than or equal to 15%.) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 29/03/2021 |
| Completion date | 31/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 34 |
| Key inclusion criteria | 1. Age greater than or equal to 18 years 2. With spontaneous ventilation 3. Patients with acute circulatory failure, defined as: 3.1. Hypotension (systolic blood pressure <90 mmHg and/or mean arterial pressure <65 mmHg, or drop in mean arterial pressure ≥40 mmHg from baseline), and/or 3.2. Use of vasopressors, associated with: 3.3. Signs of hypoperfusion (altered mental state, oligoanuria, lactate greater than or equal to 2 mmol/L, clinical skin changes associated with hypoperfusion) |
| Key exclusion criteria | 1. Presence of atrial fibrillation 2. Invasive mechanical ventilation in controlled modalities 3. Situations in which a passive leg raising maneuver is contraindicated (head trauma, deep vein thrombosis in the pelvic limbs, intra-abdominal hypertension> 12 mmHg) 4. Patients with a poor echocardiographic window and in whom an adequate 5-chamber apical window cannot be obtained 5. Patients whose echocardiogram shows aortic stenosis and insufficiency |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 31/10/2021 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Zona Urbana Rio Tijuana
Tijuana
22010
Mexico
Sponsor information
Hospital/treatment centre
Paseo de los Héroes No 10999
Zona Urbana Río
Tijuana
22010
Mexico
| Phone | +52 6646351900 |
|---|---|
| servicios.clinicos.hti@saludangeles.com | |
| Website | https://www.hospitalesangeles.com/tijuana/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
20/05/2021: Trial's existence confirmed by Hospital Angeles Tijuana.
