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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 03-2021 |
| Sponsor | Hospital Angeles Tijuana |
| Funder | Investigator initiated and funded |
- 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
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational study |
| Secondary study design | Longitudinal study |
| Study type | Participant 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(s) |
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). |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/05/2021: Trial's existence confirmed by Hospital Angeles Tijuana.
