Cardiovascular system monitoring practices in critically ill patients

ISRCTN ISRCTN28096177
DOI https://doi.org/10.1186/ISRCTN28096177
Submission date
10/08/2022
Registration date
12/08/2022
Last edited
11/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
An analysis will be carried out on the type of monitoring of the cardiovascular system used in critical patients in the intensive care unit.

Who can participate?
Patients older than 18 years, of both sexes, and critically ill who are in the intensive care unit.

What does the study involve?
No intervention will be performed on the patients. Only demographic data and the type of monitoring used will be collected.

What are the possible benefits and risks of participating?
There are no risks or side effects since no interventions will be performed.

Where is the study run from?
Hospital Angeles Tijuana (Mexico)

When does the study start and how long is it expected to last?
August 2021 to September 2022

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Damian Gutierrez-Zarate, dr.guzda@gmail.com

Contact information

Dr Damian Gutierrez-Zarate
Principal Investigator

Paseo de los Heroes No 10999
Tijuana Baja California
22010
Mexico

ORCiD logoORCID ID 0000-0001-9353-4754
Phone +52 (664) 6351900, Ext 2099
Email medterapia.tijuana@saludangeles.mx

Study information

Study designCross-sectional multicentre study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleHemodynamic monitoring practices in intensive care units in Mexico: A cross-sectional multicenter study.
Study acronymHEMO-MX
Study objectivesThere is variability in the use of hemodynamic monitoring according to the type of hospital or the characteristics of the patient.
Ethics approval(s)Approved 09/08/2022, Hospital Angeles Tijuana, BC Mexico. Research Ethics Committee and Research Committee (Operadora de Hospital Angeles de Tijuana, SA de CV. Paseo de los Heroes No 10999, Zona Urbana Rio, CP 222010, Mexico; no telephone number provided; dirmedica.hti@saludangeles.com), ref: non e provided
Health condition(s) or problem(s) studiedCritically ill patients in the intensive care unit
InterventionThe data will be collected through the Google Forms tool. This will consist of 2 phases:
• The first phase will have the objective of recruiting interested units and obtaining general information about the hospital, the type of ICU, number of beds, availability of hemodynamic monitoring tools, etc.
• The second phase will take place on September 7, 2022, where demographic information will be obtained on patients admitted to the ICU and specific data on the type of hemodynamic monitoring used. The data of patients who are in the unit or are admitted that day within a 24-hour period from 7 am on September 7, 2022, to 7 am the next day will be included.
Intervention typeOther
Primary outcome measureThe primary objective of the study is to describe the practices and preferences of the types of hemodynamic monitoring used in ICUs in Mexico.
Secondary outcome measuresThe secondary objective is to identify independently associated factors to use some form of hemodynamic monitoring according to the type of hospital or the characteristics of the patient.
Overall study start date01/08/2021
Completion date08/09/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants400
Key inclusion criteriaCritically ill patients over 18 years of age who are in the ICU on an established day, including admissions.
Key exclusion criteriaPatients who are discharged due to improvement or it is not possible to obtain informed consent when required.
Date of first enrolment07/09/2022
Date of final enrolment08/09/2022

Locations

Countries of recruitment

  • Mexico

Study participating centre

Hospital Ángeles Tijuana
Paseo de los Heroes No 10999
Tijuana
22010
Mexico

Sponsor information

Colegio Mexicano de Medicina Crítica, A. C.
Other

Cincinnati 40, Departamento No 20
Col. Nochebuena
Mexico City
03720
Mexico

Phone +52 (55) 555981684
Email contacto@commec.org
Website https://commec.org/

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date13/10/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned publication in an indexed peer-reviewed journal
IPD sharing planThe raw data and the code used will be made public on the GitHub platform (https://github.com/).

Editorial Notes

11/08/2022: Trial's existence confirmed by Hospital Angeles Tijuana