Point of Care Ultrasonography In The Management of Shock: A Pilot Study

NCT ID: NCT03296891

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-10

Study Completion Date

2020-11-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This project aims to determine the feasibility of conducting a randomized controlled trial investigating point of care ultrasound guided resuscitation compared with usual care in the management of shock at the Critical Care Trauma Centre (CCTC) in London Health Science Centre (LHSC).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shock Hypotension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ultrasonography Point-of-care ultrasound Resuscitation Critical Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PoCUS Guided Resuscitation of Shock

Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock.

Group Type ACTIVE_COMPARATOR

PoCUS Guided Resuscitation of Shock

Intervention Type OTHER

Point-of-care ultrasound (PoCUS) will be used to guide resuscitation of the participant with shock. A PoCUS study will consist of limited echocardiography (LE) and thoracic ultrasound (TUS).

Usual Care

Participants randomized to the 'usual care' arm of the study will be suggested to have the following guide resuscitation: 1) Pulse pressure variation (PPV), stroke volume variation (SVV) and/or systolic pressure variation (SPV) on their arterial line, 2) central venous pressure (CVP) and oxygen saturation(ScvO2) measurement, 3) Passive leg raise (PLR) maneuver, and/or 4) pulmonary artery catheter

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PoCUS Guided Resuscitation of Shock

Point-of-care ultrasound (PoCUS) will be used to guide resuscitation of the participant with shock. A PoCUS study will consist of limited echocardiography (LE) and thoracic ultrasound (TUS).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients deemed by the clinician to be in shock for any reason and has 3 out of 4 of the following:

1. Lactate greater than or equal to 2.2 mmol/L
2. AKIN stage I or greater or Urine output less than 0.5 cc/hr
3. Altered level of consciousness due to shock or requiring invasive mechanical ventilation as a result of shock
4. Vasoactive agents required to maintain a mean arterial pressure greater than 65 mmHg.

Exclusion Criteria

1. Pregnant patients
2. Participants who have already undergone a PoCUS study (as defined in the protocol for this study) within the past 48 hours
3. Participants who have restrictions on their goals of care at the time of ICU admission (including patients refusing blood products).
4. Patients post cardiac arrest who are not obeying commands
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

London Health Science Center - Critical Care Trauma Center

London, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

109038

Identifier Type: -

Identifier Source: org_study_id