Difficult Intubation Clinical Trial
— FRIDA-ReaOfficial title:
Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units(ICU)
Verified date | March 2013 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Difficult intubation is challenging in intensive care units. There are limited data regarding risk factors of difficult intubation in ICU. The primary purpose of the investigators study is to assess the risk factors of difficult airway in adults in ICU.
Status | Completed |
Enrollment | 1400 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - More or equal to 18 years old - Men and women - Informed patient - Affiliated or benefit from an disease insurance - Available for a 28 days follow-up - Intubated patients in Intensive Care Unit Exclusion Criteria: - Law protected patients - Opposed to participate to study |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Montpellier, Saint Eloi | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difficult intubation | According to ASA criteria, difficult intubation is measured by attempts lasting more than 10 min or more than two attempts | until to 10 minutes | |
Secondary | Complications of intubation in ICU | Respiratory (inhalation, oesophageal intubation, SpO2<80%) Hemodynamic(SAP<65 mm Hg, elevated or low cardiac frequency,rythm troubles, heart attack), Neurologic (agitation), Local (dental trauma, laryngal trauma), Death Complications occuring during one hour after intubation: respiratory (major desaturation: SpO2<80%, pneumothorax, persistent hypoxia with SpO2<80%), hemodynamic (persistent hypotension: SAP<90 mm Hg despite of vascular filling, rythm troubles, heart attack, introduction or majoration of amines posology), neurologic(agitation), death |
up to one hour after intubation | |
Secondary | Mortality at 28 days after difficult intubation | Survival status at Day 28 or date of death if patient dead before. | up to 28 days after difficult intubation | |
Secondary | Incidence of difficult intubation in ICU | up to day 28 |
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