- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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)
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Ricardo Marañon
- Numero di telefono: +34 91 502 12
- Email: ricardo@semicyuc.org
Backup dei contatti dello studio
- Nome: Josep Trenado, MD, PhD
- Numero di telefono: +34620076216
- Email: jtrenaal@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients undergoing tracheal intubation in ICU
Exclusion Criteria:
- Intubation outside ICU
- Cardiac arrest at time of intubation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Major peri-intubation complications
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
First-pass intubation success
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Jose Garmacho- Montero, MD, PhD, Hospital Universitario Virgen del Rocio, Sevilla
- Investigatore principale: Federico Gordo-Vidal, MD, PhD, Hospital Universitario del Henares
- Investigatore principale: Jose Luis Garcia - Garmendia, MD, PhD, Hospital San Juan de Dios del Aljarafe
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Intupros2-3
Piano per i dati dei singoli partecipanti (IPD)
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