Critical Illness Clinical Trial
— INTUBEOfficial title:
INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients
NCT number | NCT03616054 |
Other study ID # | INTUBE |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | September 30, 2019 |
Verified date | February 2020 |
Source | Azienda Ospedaliera San Gerardo di Monza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 3600 |
Est. completion date | September 30, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Critically ill patients undergoing in-hospital endotracheal intubation. Exclusion Criteria: - Intubation performed in the out-of-hospital setting; - Intubation during cardiac arrest; - Intubation performed only for anaesthesia. |
Country | Name | City | State |
---|---|---|---|
Italy | ASST Monza - University Hospital San Gerardo | Monza |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera San Gerardo di Monza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major intubation-related complication | At least one of the following (composite outcome): Severe hypoxemia (SpO2 < 80%) occurring within 30 minutes from intubation Cardiac arrest occurring within 30 minutes from intubation Cardiovascular collapse (at least one of the following), occurring within 30 minutes from intubation: Systolic arterial pressure < 65 mmHg recorded 1 time SAP < 90 mmHg for > 30 minutes New need of vasopressors/their increase and/or fluid load > 15 ml/kg to maintain the target blood pressure. |
30 minutes | |
Secondary | Cardiac arrhythmia | New onset of any supraventricular or ventricular arrhythmia | 30 minutes | |
Secondary | Difficult intubation | > 2 laryngoscopic attempts | 30 minutes | |
Secondary | Cannot intubate cannot oxygenate scenario (CICO) | 'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway | 30 minutes | |
Secondary | Emergency front of neck airway (FONA) | Cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy | 30 minutes | |
Secondary | Aspiration of gastric contents | Inhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract | 24 hours | |
Secondary | Oesophageal intubation | Accidental placement of endotracheal tube into the oesophagus | 30 minutes | |
Secondary | Pneumothorax/pneumo-mediastinum | Pleural/mediastinal air collection attributable to traumatic airway management | 24 hours | |
Secondary | Dental injury | Any notable change to the patient's dentition attributable to the procedure of endotracheal intubation | 24 hours | |
Secondary | Airways injury | Any detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration) | 24 hours | |
Secondary | ICU mortality | Survival status at ICU discharge | up to 12 weeks |
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