Critical Illness Clinical Trial
Official title:
INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients
Endotracheal intubation (ETI) is a potentially life-threatening procedure for critically ill
patients and major severe complications such as severe hypoxia, cardiovascular collapse and
cardiac arrest are common. Despite the high risk of the procedure, different interventions
lack high-quality evidence and the investigators hypothesize that a heterogeneous practice
among different centres and geographical areas may be found.
The investigators designed a large international observational study aiming at prospectively
collecting data on the current impact of ETI-related adverse events and current airway
management practice in critically ill patients. Investigators will collect data on all
consecutive in-hospital (intensive care unit, emergency department and wards) ETIs performed
in adult critically patients.
This study aims at prospectively collecting data on the current morbidity and mortality of
ETI-related adverse events and current airway management practice in adult critically ill
patients. Investigators designed a large international study calling for participation all
institutions caring critically ill patients worldwide.
Inclusion criteria
Investigators will include all adult (≥ 18 years old) critically ill patients undergoing
intubation during the period of observation. Investigators will consider all in-hospital
intubations. Critically ill will be defined those patients with a life-threatening condition
requiring intubation for either cardiorespiratory failure or airway protection.
Exclusion Criteria
- Intubation performed in the out-of-hospital setting
- Intubation during cardiac arrest
- Intubation performed for anaesthesia
Primary Outcome
Major ETI-related adverse events - composite outcome (severe hypoxemia, cardiac arrest and
cardiovascular collapse - see further for definitions)
Secondary Outcomes
Minor ETI-related adverse events and ICU mortality (see further for definitions).
Sample size
Investigators' aim is to collect data from 1000 intubation- related major complications. From
a previously published report (Jaber 2006) the expected incidence of at least one major
complication is 28%. Therefore investigators plan to recruit data from 3600 endotracheal
intubations. Intubation rate may vary from 0.5 to 2 ETIs/day according to different centres
(e.g. total hospital beds, number of ICUs and ICU beds) and local policies. Each centre will
be asked to collect data from 20 ETIs. A maximum time window of 8 weeks will be allowed for
each centre (i.e. for centres with a slower recruitment rate, data collection will stop after
8 weeks irrespective of total number of ETIs collected data). Investigators plan to recruit
at least 180 centres worldwide.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
Recruiting |
NCT06037928 -
Plasma Sodium and Sodium Administration in the ICU
|
||
Completed |
NCT03671447 -
Enhanced Recovery After Intensive Care (ERIC)
|
N/A | |
Recruiting |
NCT03941002 -
Continuous Evaluation of Diaphragm Function
|
N/A | |
Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
Completed |
NCT04239209 -
Effect of Intensivist Communication on Surrogate Prognosis Interpretation
|
N/A | |
Completed |
NCT05531305 -
Longitudinal Changes in Muscle Mass After Intensive Care
|
N/A | |
Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
Completed |
NCT02916004 -
The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
|
N/A | |
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Completed |
NCT04479254 -
The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)
|
N/A | |
Recruiting |
NCT04475666 -
Replacing Protein Via Enteral Nutrition in Critically Ill Patients
|
N/A | |
Not yet recruiting |
NCT04516395 -
Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae
|
N/A | |
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Withdrawn |
NCT04043091 -
Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction
|
N/A | |
Recruiting |
NCT02922998 -
CD64 and Antibiotics in Human Sepsis
|
N/A | |
Recruiting |
NCT02989051 -
Fluid Restriction Keeps Children Dry
|
Phase 2/Phase 3 | |
Completed |
NCT03048487 -
Protein Consumption in Critically Ill Patients
|
||
Completed |
NCT02899208 -
Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?
|
N/A | |
Recruiting |
NCT02163109 -
Oxygen Consumption in Critical Illness
|