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NCT Number: NCT07807358

INTUPROS 2-3: Improving First-Pass Intubation Success and Reducing Complications in ICU Patients

This national, multicenter, prospective cohort study aims to determine the prevalence and risk factors associated with major peri-intubation complications in critically ill adult patients undergoing tracheal intubation in intensive care units (ICUs), and to compare these findings with those previously reported in the INTUPROS 1 study. Additionally, the study will evaluate the impact of a structured educational intervention on airway management practices and clinical outcomes through a pre- and post-intervention design

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Key information

About this study

Tracheal intubation in critically ill patients admitted to intensive care units (ICUs) is associated with a high risk of severe complications, including cardiovascular instability, severe hypoxemia, cardiac arrest, and death. Previous multicenter studies, including the INTUPROS 1 study, have reported major peri-intubation complication rates of approximately 40-45%, emphasizing the need for improved airway management strategies. Despite advances in airway devices and monitoring techniques, first-pass intubation success rates and complication rates have not significantly improved over time. Variability in clinical practice, differences in operator experience, and inconsistent use of standardized protocols may contribute to these outcomes. The INTUPROS 2-3 study is a national, multicenter, prospective cohort study designed to evaluate current airway management practices and their associated outcomes in ICU patients, as well as to assess the effect of a structured educational intervention.

The study is conducted in three sequential phases:

INTUPROS 2 (pre-intervention phase): prospective observational data collection to determine the prevalence and risk factors of major peri-intubation complications, and to compare these results with those previously reported in INTUPROS 1. Educational intervention phase: implementation of a structured training program including simulation-based airway management training, dissemination of standardized protocols, promotion of videolaryngoscopy and capnography use, and distribution of educational materials. INTUPROS 3 (post-intervention phase): prospective observational data collection using the same methodology as in the pre-intervention phase to evaluate changes in airway management practices and clinical outcomes following the intervention. The primary objective is to determine the prevalence and identify risk factors associated with major peri-intubation complications within 30 minutes of the procedure. Major complications are defined as a composite endpoint including cardiovascular instability, severe hypoxemia, cardiac arrest requiring resuscitation, or death. Secondary objectives include evaluating first-pass intubation success, incidence of hemodynamic instability, use of airway devices such as videolaryngoscopy, pharmacological strategies used during intubation, number of intubation attempts, and adherence to recommended airway management practices. This quasi-experimental, before-and-after design allows both epidemiological characterization of current practices and assessment of the real-world impact of a national educational quality improvement program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing tracheal intubation in ICU

Exclusion criteria

  • Intubation outside ICU
  • Cardiac arrest at time of intubation

Treatment and study plan

Primary outcomes

  1. Major peri-intubation complications

    Time frame: Within 30 minutes from the start of the tracheal intubation procedure.

    Number and proportion of patients experiencing at least one major peri-intubation complication during tracheal intubation in the intensive care unit. Major peri-intubation complications include cardiovascular instability, severe hypoxemia, cardiac arrest requiring resuscitation, and death. Risk factors independently associated with major peri-intubation complications will also be analyzed, and the results will be compared with those previously reported in the INTUPROS 1 study.

Secondary outcomes

  1. First-pass intubation success

    Time frame: During the tracheal intubation procedure, at the first intubation attempt.

    Number and proportion of patients in whom successful tracheal intubation is achieved on the first intubation attempt. The first-pass intubation success rate will be compared with that previously reported in the INTUPROS 1 study.

  2. Use of videolaryngoscopy and type of videolaryngoscope

    Time frame: During the tracheal intubation procedure.

    Number and proportion of tracheal intubations in which videolaryngoscopy is used. The type of videolaryngoscope used and its order of use during the intubation procedure will also be recorded.

  3. Pharmacological agents used to facilitate tracheal intubation

    Time frame: During the tracheal intubation procedure.

    Number and proportion of patients receiving each pharmacological agent used to facilitate tracheal intubation. The agents used and their doses will be recorded, and patterns of pharmacological agent use will be compared with those previously reported in the INTUPROS 1 study.

  4. Predictive performance of the INTUPROS difficult airway prediction score

    Time frame: During the tracheal intubation procedure.

    Predictive performance for difficult tracheal intubation of the difficult airway prediction score derived from the INTUPROS 1 database. The prediction score does not include the MACOCHA score.

Study contacts

Contact information is provided by the study sponsor or research team.

Josep Trenado, MD, PhD

CONTACT

[email protected]

+34620076216

Ricardo Marañon

CONTACT

[email protected]

+34 91 502 12

Sponsors and collaborators

Lead sponsor

Spanish Society of Critical Care Medicine and Coronary Units

Other

Collaborators

  • Henares University Hospital
  • Hospital Mutua de Terrassa
  • Hospital San Juan de Dios del Aljarafe de Sevilla
  • Hospitales Universitarios Virgen del Rocío

Registry information

Official study title

National Program to Improve First-Pass Intubation Success and Reduce Major Complications During Tracheal Intubation in Intensive Care Units: A Quasi- Experimental Study Following an Educational Intervention (INTUPROS 2 and 3)

Acronym: INTUPROS

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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