- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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)
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Ricardo Marañon
- Telefonnummer: +34 91 502 12
- E-Mail: ricardo@semicyuc.org
Studieren Sie die Kontaktsicherung
- Name: Josep Trenado, MD, PhD
- Telefonnummer: +34620076216
- E-Mail: jtrenaal@gmail.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Patients undergoing tracheal intubation in ICU
Exclusion Criteria:
- Intubation outside ICU
- Cardiac arrest at time of intubation
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Major peri-intubation complications
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
First-pass intubation success
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Jose Garmacho- Montero, MD, PhD, Hospital Universitario Virgen del Rocio, Sevilla
- Hauptermittler: Federico Gordo-Vidal, MD, PhD, Hospital Universitario del Henares
- Hauptermittler: Jose Luis Garcia - Garmendia, MD, PhD, Hospital San Juan de Dios del Aljarafe
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Intupros2-3
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .