Critical IllnessINTUBENCT03616054
International Observational Study on Airway Management in Critically Ill Patients
An observational study of Critical Illness and Respiratory Failure, run by Azienda Ospedaliera San Gerardo di Monza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Respiratory Failure, Hemodynamic Instability
- How many people
- 3,600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Critically ill patients undergoing in-hospital endotracheal intubation.
Who cannot join
- Intubation performed in the out-of-hospital setting;
- Intubation during cardiac arrest;
- Intubation performed only for anaesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Critical Illness, Respiratory Failure, Hemodynamic Instability, Coma
- Keywords
- Airway management
- Medical subject headings
- Critical Illness, Respiratory Insufficiency, Coma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (10)
Cardiac arrhythmia
New onset of any supraventricular or ventricular arrhythmia
Measured: 30 minutes
Difficult intubation
> 2 laryngoscopic attempts
Measured: 30 minutes
Cannot intubate cannot oxygenate scenario (CICO)
'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway
Measured: 30 minutes
Emergency front of neck airway (FONA)
Cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy
Measured: 30 minutes
Aspiration of gastric contents
Inhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract
Measured: 24 hours
Oesophageal intubation
Accidental placement of endotracheal tube into the oesophagus
Measured: 30 minutes
Pneumothorax/pneumo-mediastinum
Pleural/mediastinal air collection attributable to traumatic airway management
Measured: 24 hours
Dental injury
Any notable change to the patient's dentition attributable to the procedure of endotracheal intubation
Measured: 24 hours
Airways injury
Any detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration)
Measured: 24 hours
ICU mortality
Survival status at ICU discharge
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Oct 2018
- Primary completion31 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Gerardo di Monza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Russotto, MD, Azienda Ospedaliera San Gerardo di Monza
- Investigators
- Vincenzo Russotto, MD, Principal investigator, Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, ItalyGiacomo Bellani, MD, PhD, Principal investigator, Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, Italy; University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616054
- Sponsor's protocol ID
- INTUBE
- Acronym
- INTUBE
- Status last verified
- Feb 2020
- First submitted
- 15 Jul 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Russotto V, Laffey JG, Tassistro E, Myatra SN, Rezoagli E, Foti G, Antolini L, Valsecchi MG, Bauer PR, Szuldrzynski K, Camporota L, Greif R, Higgs A, Parotto M, Fumagalli R, Sorbello M, Robba C, Grasselli G, Bellani G, Caironi P, Lascarrou JB; INTUBE Study Investigators. Peri-intubation complications in critically ill obese patients: a secondary analysis of the international INTUBE cohort. Crit Care. 2025 May 13;29(1):192. doi: 10.1186/s13054-025-05419-2.
PubMed 40361245Russotto V, Lascarrou JB, Tassistro E, Parotto M, Antolini L, Bauer P, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Grasselli G, Valsecchi MG, Fumagalli R, Foti G, Caironi P, Bellani G, Laffey JG, Myatra SN; INTUBE Study Investigators. Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study. Br J Anaesth. 2023 Sep;131(3):607-616. doi: 10.1016/j.bja.2023.04.022. Epub 2023 May 17.
PubMed 37208282Russotto V, Tassistro E, Myatra SN, Parotto M, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Pesenti A, Valsecchi MG, Fumagalli R, Foti G, Bellani G, Laffey JG. Peri-intubation Cardiovascular Collapse in Patients Who Are Critically Ill: Insights from the INTUBE Study. Am J Respir Crit Care Med. 2022 Aug 15;206(4):449-458. doi: 10.1164/rccm.202111-2575OC.
PubMed 35536310
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03616054
- Acronym / sponsor ID
- INTUBE / INTUBE
- Conditions
- Critical Illness, Respiratory Failure, Hemodynamic Instability, Coma
- Keywords
- Airway management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,600 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Gerardo di MonzaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Critically ill patients undergoing in-hospital endotracheal intubation.
Key exclusion criteria (3 listed)
- Intubation performed in the out-of-hospital setting;
- Intubation during cardiac arrest;
- Intubation performed only for anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Cardiac arrhythmia
Time frame: 30 minutes
Difficult intubation
Time frame: 30 minutes
Cannot intubate cannot oxygenate scenario (CICO)
Time frame: 30 minutes
Emergency front of neck airway (FONA)
Time frame: 30 minutes
Aspiration of gastric contents
Time frame: 24 hours
Oesophageal intubation
Time frame: 30 minutes
Pneumothorax/pneumo-mediastinum
Time frame: 24 hours
Dental injury
Time frame: 24 hours
Airways injury
Time frame: 24 hours
ICU mortality
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 40361245Russotto V, Laffey JG, Tassistro E, Myatra SN, Rezoagli E, Foti G, Antolini L, Valsecchi MG, Bauer PR, Szuldrzynski K, Camporota L, Greif R, Higgs A, Parotto M, Fumagalli R, Sorbello M, Robba C, Grasselli G, Bellani G, Caironi P, Lascarrou JB; INTUBE Study Investigators. Peri-intubation complications in critically ill obese patients: a secondary analysis of the international INTUBE cohort. Crit Care. 2025 May 13;29(1):192. doi: 10.1186/s13054-025-05419-2.
- Derived from this study: PubMed 37208282Russotto V, Lascarrou JB, Tassistro E, Parotto M, Antolini L, Bauer P, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Grasselli G, Valsecchi MG, Fumagalli R, Foti G, Caironi P, Bellani G, Laffey JG, Myatra SN; INTUBE Study Investigators. Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study. Br J Anaesth. 2023 Sep;131(3):607-616. doi: 10.1016/j.bja.2023.04.022. Epub 2023 May 17.
- Derived from this study: PubMed 35536310Russotto V, Tassistro E, Myatra SN, Parotto M, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Pesenti A, Valsecchi MG, Fumagalli R, Foti G, Bellani G, Laffey JG. Peri-intubation Cardiovascular Collapse in Patients Who Are Critically Ill: Insights from the INTUBE Study. Am J Respir Crit Care Med. 2022 Aug 15;206(4):449-458. doi: 10.1164/rccm.202111-2575OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Russotto, MD principal investigator
Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, Italy
Giacomo Bellani, MD, PhD principal investigator
Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, Italy; University of Milano Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Respiratory Failure, run by Azienda Ospedaliera San Gerardo di Monza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major intubation-related complication (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03616054, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.