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

NCT07807358 | Not Yet Recruiting

• 1 other identifier: Intupros2-3
• Study Type: observational
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

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

Conditions

Critical Illness; Airway Management Assessment; Tracheal Intubation; Complications

Keywords

airway management; intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• First-pass intubation success

  During the tracheal intubation procedure, at the first intubation attempt.

• Use of videolaryngoscopy and type of videolaryngoscope

  During the tracheal intubation procedure.

• Pharmacological agents used to facilitate tracheal intubation

  During the tracheal intubation procedure.

• Predictive performance of the INTUPROS difficult airway prediction score

  During the tracheal intubation procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients intubated in the ICU

You may qualify if:

• Patients undergoing tracheal intubation in ICU

You may not qualify if:

• Intubation outside ICU
• Cardiac arrest at time of intubation

Sponsors & Collaborators

• Spanish Society of Critical Care Medicine and Coronary Units: lead
• Hospitales Universitarios Virgen del Rocío: collaborator
• Henares University Hospital: collaborator
• Hospital San Juan de Dios del Aljarafe de Sevilla: collaborator
• Hospital Mutua de Terrassa: collaborator

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Marañon

CONTACT

+34 91 502 12; ricardo@semicyuc.org

Josep Trenado, MD, PhD

CONTACT

+34620076216; jtrenaal@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-08