- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07807358
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)
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Ricardo Marañon
- Telefonnummer: +34 91 502 12
- E-mail: ricardo@semicyuc.org
Undersøgelse Kontakt Backup
- Navn: Josep Trenado, MD, PhD
- Telefonnummer: +34620076216
- E-mail: jtrenaal@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients undergoing tracheal intubation in ICU
Exclusion Criteria:
- Intubation outside ICU
- Cardiac arrest at time of intubation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Major peri-intubation complications
Tidsramme: 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.
|
Within 30 minutes from the start of the tracheal intubation procedure.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
First-pass intubation success
Tidsramme: 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.
|
During the tracheal intubation procedure, at the first intubation attempt.
|
|
Use of videolaryngoscopy and type of videolaryngoscope
Tidsramme: 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.
|
During the tracheal intubation procedure.
|
|
Pharmacological agents used to facilitate tracheal intubation
Tidsramme: 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.
|
During the tracheal intubation procedure.
|
|
Predictive performance of the INTUPROS difficult airway prediction score
Tidsramme: 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.
|
During the tracheal intubation procedure.
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jose Garmacho- Montero, MD, PhD, Hospital Universitario Virgen del Rocio, Sevilla
- Ledende efterforsker: Federico Gordo-Vidal, MD, PhD, Hospital Universitario del Henares
- Ledende efterforsker: Jose Luis Garcia - Garmendia, MD, PhD, Hospital San Juan de Dios del Aljarafe
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Intupros2-3
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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