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

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Complications; Tracheal Intubation; Airway Management Assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: Ricardo Marañon; Phone Number: +34 91 502 12; Email: ricardo@semicyuc.org
• Study Contact Backup: Name: Josep Trenado, MD, PhD; Phone Number: +34620076216; Email: jtrenaal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients intubated in the ICU

Description

Inclusion Criteria:

• Patients undergoing tracheal intubation in ICU

Exclusion Criteria:

• Intubation outside ICU
• Cardiac arrest at time of intubation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 30 minutes from the start of the tracheal intubation procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	During the tracheal intubation procedure.

Collaborators and Investigators

• Sponsor: Spanish Society of Critical Care Medicine and Coronary Units
• Collaborators: Hospital Mutua de Terrassa; Hospitales Universitarios Virgen del Rocío; Henares University Hospital; Hospital San Juan de Dios del Aljarafe de Sevilla
• Investigators: Principal Investigator: Jose Garmacho- Montero, MD, PhD, Hospital Universitario Virgen del Rocio, Sevilla; Principal Investigator: Federico Gordo-Vidal, MD, PhD, Hospital Universitario del Henares; Principal Investigator: Jose Luis Garcia - Garmendia, MD, PhD, Hospital San Juan de Dios del Aljarafe

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: airway management; intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: Intupros2-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No