A Systematic Echography During Intubation Procedure to Predict Cardiovascular Collapse
EPIC
A Systematic Ultrasound Assessment During Intubation Procedure to Predict Cardiovascular Collapse Related to Intubation in the Intensive Care Unit: a Prospective, Multiple-center Study
1 other identifier
observational
70
1 country
3
Brief Summary
In the operating room, most intubation procedures (IP) are scheduled and performed on hemodynamically stable patients. In the ICU, IP is frequently performed in emergent patients, because of unstable hemodynamics and/or acute respiratory failure, and complicated by a subsequent cardiovascular collapse. Transthoracic echocardiography (TTE) has become readily available in most ICUs for several years. Echocardiography enables to perform a noninvasive hemodynamic evaluation (cardiac function and volemia status). We hypothesized that performing a TTE prior to IP may help to predict cardiovascular collapse and its components.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
3 active sites
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
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedStudy Start
First participant enrolled
June 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2018
CompletedAugust 13, 2019
July 1, 2019
Same day
April 13, 2017
August 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Subsequent cardiovascular collapse related to intubation
Mean arterial pressure drop \< 60 mmHg
Within 15 minutes of intubation
Secondary Outcomes (1)
Ultrasound parameters to predict fluid responsiveness
30 minutes before intubation, less than 30 minutes after intubation, 1 minutes after lifting legs and 3 hours after intubation
Eligibility Criteria
Patient admitted to ICU
You may qualify if:
- Patient requiring endotracheal intubation
You may not qualify if:
- Age \< 18 yrs
- Pregnancy
- Amputation of a lower limb
- Passing leg raising contraindication: intracranial hypertension with invasive monitoring, fracture of the pelvis or limbs
- Patients under administrative protective measures
- Severe cardiovascular collapse before intubation
- Severe cardiogenic pulmonary oedema
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hôpital d'Instruction des Armées Clermont Tonnerre
Brest, 29200, France
CHRU de Brest
Brest, 29609, France
Centre Hospitalier des Pays de Morlaix
Morlaix, 29672, France
Related Publications (1)
Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, Verzilli D, Jonquet O, Eledjam JJ, Lefrant JY. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010 Feb;36(2):248-55. doi: 10.1007/s00134-009-1717-8. Epub 2009 Nov 17.
PMID: 19921148BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
JEAN-MICHEL Vanessa, M.D.
CHRU Brest Hospital Brittany Occidental University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2017
First Posted
June 12, 2017
Study Start
June 21, 2017
Primary Completion
June 21, 2017
Study Completion
October 19, 2018
Last Updated
August 13, 2019
Record last verified: 2019-07