Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Optimiser les soins aux patients gravement malades à UCHealth en libéralisant l'O2 cible chez les patients en soins intensifs ventilés mécaniquement

25 septembre 2026 mis à jour par: University of Colorado, Denver

A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range.

Aperçu de l'étude

Description détaillée

This project will be a multi-hospital, cluster randomized study to implement a targeted oxygen saturation (SpO2) range of 90-96% in adult patients receiving mechanical ventilation (MV) using a multimodal educational intervention strategy. Hospital-level randomization to receive the intervention will occur sequentially for a phased roll-out of multimodal education and real-time informatics tools to enhance adherence of the targeted SpO2 range in eligible mechanically ventilated patients. This phased roll-out is achieved through a stepped wedge approach in a one-way crossover design in which all participating hospital ICUs will ultimately implement the intervention, and the timing of the intervention implementation is randomly ordered. The intervention will occur using 4 clusters that switch from control to intervention at 4 pre-determined time points, 1 for each cluster. For each switch, the design incorporates a 2-week transition period for staff education/implementation at each cluster, during which training will be delivered to each participating hospital to improve implementation. The investigators will provide standardized education and materials to local stakeholders for hospital and ICU-level implementation. During the transition period, the cluster cannot be considered as either receiving the structured usual care intervention (education-based intervention) or the unstructured usual care control (current state, no education-based intervention), and thus patients treated in the hospital during that period will not be enrolled or included in the analysis.

The investigators define a targeted SpO2 range (90-96%), PaO2 (60-100 mmHg) target based on thresholds defined in recent published work that incorporates expert opinions from the field and includes consensus among critical care COGG members that represent UCHealth hospitals throughout the North, South, and Metro regions as well as the site locations at which the intervention is proposed to occur. The oxygen target range will be defined by an oxygen saturation (SpO2) 90-96%, and when arterial blood gases are available, an arterial oxygen pressure (PaO2) 60-100 mmHg. The intervention will start when patients requiring mechanical ventilation arrive to an ICU in a participating hospital and the intervention will continue for any period of invasive mechanical ventilation required during ICU stay. A project goal is to achieve adherence to >95% of eligible patient-hours spent in the target SpO2 range, excluding time on FiO2 30% when above SpO2 96% or time on FiO2 100% when below SpO2 90%. Each hospital site will contribute pre-implementation (control) and post-implementation (intervention) data, with the start of the consensus-based intervention period defined by the randomized timing in the stepped wedge design.

Patients will be ventilated with a standardized UCHealth-wide mechanical ventilation order-set to achieve these SpO2 and PaO2 goals. These order-sets included the ARDSNetwork low- and high-PEEP/FiO2 arms, as well as developed protocols for alternative modes of ventilation, such as APRV which can be used at the provider teams' discretion. Data collection for Phase I began 9/1/2024 and will end 9/15/2025.

Once all hospital clusters have transitioned to the intervention phase, a nested study will commence that involves a patient-level intervention for mechanically ventilated patients experiencing residual occult hypoxemia among participating UCHealth ICUs (Phase II). Data collection for Phase II began 3/25/2026 and will end 7/31/2026. These patients will be identified automatically in the EHR (EPIC) by comparing the SaO2 from an ABG laboratory procedure to contemporaneous SpO2 flowsheet row values and then will be randomized 1:1 to either an active or silent notification delivered in real-time to members of the provider team alerting them to each OH instance, with a 12-hour notification lockout. A unique research study order will be created in EPIC for this nested, Phase II study to facilitate tracking of outcomes for patients randomized to silent and active notification arms in coordination with a health data compass analyst (HDC).

Educational interventions will include:

  1. Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase.
  2. EPIC-generated push notification to (1) alert providers in real-time to the presence of OH in their patient with a time-stamp based on SpO2 and SaO2 values compared from vital signs and arterial blood gas oxygen saturation respectively, and (2) inform them of the potential associations of OH with worse outcomes in similar, critically ill patients, and (3) choices for potential changes to management, including an "acknowledge only" option

Type d'étude

Interventionnel

Inscription (Estimé)

3600

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • University of Colorado

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Admission to ICU and requiring invasive mechanical ventilation

Exclusion Criteria:

  • Transferred patients from outside the UCHealth system*:
  • Patients with pre-existing disease that requires chronic use of positive pressure ventilation delivered through a tracheostomy*:
  • Pregnant women:
  • Prisoners
  • Patients receiving mechanical ventilation for less than twelve hours

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Educational intervention

SP02 target ranges will be 90-96%. Education about the specific oxygen targets will be provided to the clinical teams. Real time feedback on adherence to the Sp02 target range will be provided by virtual respiratory therapists.

1) Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase.

Autre: Educational intervention Epic alert

An education-based intervention that also focuses on mitigating Occult Hypoxemia in mechanically ventilated patients, and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic as

  1. alert (notification) the providers of sustained occult hypoxemia or
  2. silent alert The investigators are observing physician behavior in response to alerting them that a patient has occult hypoxemia via an Epic alert.

An education-based intervention that focuses on mitigating Occult Hypoxemia in mechanically ventilated patients and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic to as

  1. alert (notification) the providers of sustained occult hypoxemia
  2. silent alert

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Ventilator Free Days (Phase I,II)
Délai: 30 Days

The number of days the patient will be free of mechanical ventilation

30 Days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
instances of occult hypoxemia (Phase I,II)
Délai: 30 days

arterial oxygen saturation below 88% when the Sp02 is greater than 90% among all patients

30 days
ICU free days (Phase I,II)
Délai: 90 days

Number of days patients are not in the ICU

90 days
Hospital free days (Phase I, II)
Délai: 90 DAYS

number of days patients are not hospitalized

90 DAYS
90 Day in hospital mortality (Phase I, II)
Délai: 90 days

Patients that die in the hospital before day 90

90 days
Time to Mortality to day 90 (Phase I,II)
Délai: 90 Days

Patients that die within 90 days

90 Days
Oxygen status at discharge (Phase I, II)
Délai: 90 days

What if any oxygen the patient is on at discharge

90 days
Incidence of needing high level 02 support (Phase I, II)
Délai: 90 days

The number of times that the patients is in need of heated-high flow nasal cannula (HHFNC) / non-invasive positive pressure ventilation (NIPPV)) after extubation

90 days
Discharge disposition (Phase I, II)
Délai: 90 days

Place the patient is discharged to

90 days
Changes to mechanical ventilation order set (Phase II)
Délai: 4 hours

Quantify the number of changes made to the ventilator order set to attempt to deliver more oxygen to the blood. This will capture FIO2, PEEP, Tidal Volume, Inspiratory Pressure changes as a summary numerical unit of measure.

4 hours
Medication changes (Phase II)
Délai: 4 hours

Addition or dose change of a medication to try and eliminate occult hypoxemia will be quantified numerically. The investigators will include diuretics, inhaled vasodilators, corticosteroids, Intravenous sedatives, and intravenous paralytics in this summary statistic.

4 hours
Additional procedures in response to occult hypoxemia (Phase II)
Délai: 4 hours

The investigators will quantify the number of additional procedures that may be performed in response to occult hypoxemia. Chest X-ray, Chest CT Scan, arterial blood gas, and placement of arterial catheter procedures will be included in this summary statistic.

4 hours

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Proportion of mechanically ventilated time on SpO₂ protocol target (Phase I, II)
Délai: 30 days

Reported between index intubation and 30 days later. The SpO₂ protocol target is defined as SpO₂ 90-96% or receiving no oxygen (FiO₂ 0.21 with SpO₂>96%) or maximal oxygen (FiO₂ 1.00, with SpO₂ below 90%) while requiring mechanical ventilation.

30 days
Proportion of participants receiving high levels of oxygen support (FiO₂ >0.80) (Phase I, II)
Délai: 30 days

Defined as >2 hours while requiring mechanical ventilation. This includes only the time the patient is in the ICU and receiving any amount of respiratory support (IMV or otherwise).

30 days
Proportion of time at high levels of oxygen support (FiO₂ >0.80) (Phase I, II)
Délai: 30 days

Quantified during mechanical ventilation.

30 days
Proportion of time receiving room air oxygen (FiO₂ 0.21) (Phase I, II)
Délai: 30 days

Quantified during mechanical ventilation.

30 days
Incidence of documented hypoxic events (SpO₂ <88% OR PaO₂ <60 mmHg) (Phase I, II)
Délai: 30 days

Quantified during mechanical ventilation.

30 days
Incidence of documented hyperoxic events (SpO₂ >98% OR PaO₂ >150 mmHg) (Phase I, II)
Délai: 30 days

Quantified during mechanical ventilation.

30 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Neil Aggarwal, MD, University of Colorado, Denver

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2024

Achèvement primaire (Estimé)

30 septembre 2026

Achèvement de l'étude (Estimé)

30 novembre 2026

Dates d'inscription aux études

Première soumission

8 juillet 2024

Première soumission répondant aux critères de contrôle qualité

8 juillet 2024

Première publication (Réel)

15 juillet 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner