An observational study in Critical Illness, Airway Management Assessment and Tracheal Intubation, sponsored by Spanish Society of Critical Care Medicine and Coronary Units. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Spanish Society of Critical Care Medicine and Coronary Units · Observational
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
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 140 across 814 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Spanish Society of Critical Care Medicine and Coronary Units is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Patients intubated in the ICU
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Exclusion Criteria:
Major peri-intubation complications
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.
Time frame: Within 30 minutes from the start of the tracheal intubation procedure.
First-pass intubation success
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.
Time frame: During the tracheal intubation procedure, at the first intubation attempt.
Use of videolaryngoscopy and type of videolaryngoscope
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.
Time frame: During the tracheal intubation procedure.
Pharmacological agents used to facilitate tracheal intubation
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.
Time frame: During the tracheal intubation procedure.
Predictive performance of the INTUPROS difficult airway prediction score
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.
Time frame: During the tracheal intubation procedure.
No study locations are listed for this record.
Plan to share: Undecided — The sharing of de-identified individual participant data has not yet been determined and will be considered upon study completion, taking into account ethical, legal, and data protection requirements.
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Nov 2027, 8 months later.
Of 439 non-industry observational studies under Critical Illness, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 8 months is below that.
Counting every sponsor, half of 442 studies reached it within 23 months; a quarter within 12 and three quarters within 46.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Spanish Society of Critical Care Medicine and Coronary Units