A Systematic Echography During Intubation Procedure to Predict Cardiovascular Collapse

Intubation Clinical Trial

— EPIC  

Official title:

A Systematic Ultrasound Assessment During Intubation Procedure to Predict Cardiovascular Collapse Related to Intubation in the Intensive Care Unit: a Prospective, Multiple-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184207
• Other study ID #: EPIC ( 29BRC17.0047)
• Status: Completed
• Start date: June 21, 2017
• Est. completion date: October 19, 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 19, 2018
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patient requiring endotracheal intubation

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Intubation
• Shock

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
France	Hôpital d'Instruction des Armées Clermont Tonnerre	Brest
France	Centre Hospitalier des Pays de Morlaix	Morlaix

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subsequent cardiovascular collapse related to intubation	Mean arterial pressure drop < 60 mmHg	Within 15 minutes of intubation
Secondary	Ultrasound parameters to predict fluid responsiveness	Transthoracic echocardiography 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