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

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)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07807358
Acronym
INTUPROS
Enrollment
1300
Registered
2026-09-08
Start date
2027-03-01
Completion date
2028-05-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management Assessment, Complications, Critical Illness, Tracheal Intubation

Keywords

airway management, intubation

Brief summary

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

Detailed description

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.

Interventions

None listed

Sponsors

Spanish Society of Critical Care Medicine and Coronary Units
Lead SponsorOTHER
Hospitales Universitarios Virgen del Rocío
CollaboratorOTHER
Henares University Hospital
CollaboratorOTHER
Hospital San Juan de Dios del Aljarafe de Sevilla
CollaboratorOTHER
Hospital Mutua de Terrassa
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing tracheal intubation in ICU

Exclusion criteria

* Intubation outside ICU * Cardiac arrest at time of intubation

Design outcomes

Primary

MeasureTime frameDescription
Major peri-intubation complicationsWithin 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

MeasureTime frameDescription
First-pass intubation successDuring 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.
Use of videolaryngoscopy and type of videolaryngoscopeDuring 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.
Pharmacological agents used to facilitate tracheal intubationDuring 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.
Predictive performance of the INTUPROS difficult airway prediction scoreDuring 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.

Contacts

CONTACTRicardo Marañon
ricardo@semicyuc.org+34 91 502 12
CONTACTJosep Trenado, MD, PhD
jtrenaal@gmail.com+34620076216
PRINCIPAL_INVESTIGATORJose Garmacho- Montero, MD, PhD

Hospital Universitario Virgen del Rocio, Sevilla

PRINCIPAL_INVESTIGATORFederico Gordo-Vidal, MD, PhD

Hospital Universitario del Henares

PRINCIPAL_INVESTIGATORJose Luis Garcia - Garmendia, MD, PhD

Hospital San Juan de Dios del Aljarafe

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026