International Observational Study on Airway Management in Critically Ill Patients (INTUBE)

• ClinicalTrials.gov Identifier: NCT03616054
• Recruitment Status: Completed
• First Posted: August 6, 2018
• Last Update Posted: February 13, 2020
• Sponsor: Azienda Ospedaliera San Gerardo di Monza
• Information provided by (Responsible Party): Vincenzo Russotto, MD, Azienda Ospedaliera San Gerardo di Monza

Study Description

Brief Summary:

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.

Condition or disease
Critical Illness; Respiratory Failure; Hemodynamic Instability; Coma

Detailed Description:

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 3600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients
• Actual Study Start Date: October 1, 2018
• Actual Primary Completion Date: July 31, 2019
• Actual Study Completion Date: September 30, 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Major intubation-related complication [ Time Frame: 30 minutes ]

   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.

Secondary Outcome Measures :

1. Cardiac arrhythmia [ Time Frame: 30 minutes ]
   New onset of any supraventricular or ventricular arrhythmia
2. Difficult intubation [ Time Frame: 30 minutes ]
   > 2 laryngoscopic attempts
3. Cannot intubate cannot oxygenate scenario (CICO) [ Time Frame: 30 minutes ]
   'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway
4. Emergency front of neck airway (FONA) [ Time Frame: 30 minutes ]
   Cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy
5. Aspiration of gastric contents [ Time Frame: 24 hours ]
   Inhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract
6. Oesophageal intubation [ Time Frame: 30 minutes ]
   Accidental placement of endotracheal tube into the oesophagus
7. Pneumothorax/pneumo-mediastinum [ Time Frame: 24 hours ]
   Pleural/mediastinal air collection attributable to traumatic airway management
8. Dental injury [ Time Frame: 24 hours ]
   Any notable change to the patient's dentition attributable to the procedure of endotracheal intubation
9. Airways injury [ Time Frame: 24 hours ]
   Any detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration)
10. ICU mortality [ Time Frame: up to 12 weeks ]
    Survival status at ICU discharge

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

We will include all adult (≥ 18 years old) critically ill patients undergoing intubation during the period of observation. We will consider all in-hospital intubations. We will define critically ill those patients with a life-threatening condition requiring intubation for either cardiorespiratory failure or airway protection.

Criteria

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.

Contacts and Locations

Locations

Italy

ASST Monza - University Hospital San Gerardo

Monza, Italy

Sponsors and Collaborators

Azienda Ospedaliera San Gerardo di Monza

Investigators

• Principal Investigator: Vincenzo Russotto, MD; Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, Italy
• Principal Investigator: Giacomo Bellani, MD, PhD; Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, Italy; University of Milano Bicocca

More Information

• Responsible Party: Vincenzo Russotto, MD, MD, Azienda Ospedaliera San Gerardo di Monza
• ClinicalTrials.gov Identifier: NCT03616054
• Other Study ID Numbers: INTUBE
• First Posted: August 6, 2018
• Last Update Posted: February 13, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vincenzo Russotto, MD, Azienda Ospedaliera San Gerardo di Monza:

Airway management

Additional relevant MeSH terms:

Respiratory Insufficiency; Critical Illness; Disease Attributes; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases