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Otimizando o atendimento em pacientes críticos na UCHealth, liberando o O2 alvo em pacientes de UTI com ventilação mecânica

25 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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

Tipo de estudo

Intervencional

Inscrição (Estimado)

3600

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University of Colorado

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: 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.

Outro: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Ventilator Free Days (Phase I,II)
Prazo: 30 Days

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

30 Days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
instances of occult hypoxemia (Phase I,II)
Prazo: 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)
Prazo: 90 days

Number of days patients are not in the ICU

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

number of days patients are not hospitalized

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

Patients that die in the hospital before day 90

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

Patients that die within 90 days

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

What if any oxygen the patient is on at discharge

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

Place the patient is discharged to

90 days
Changes to mechanical ventilation order set (Phase II)
Prazo: 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)
Prazo: 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)
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Proportion of mechanically ventilated time on SpO₂ protocol target (Phase I, II)
Prazo: 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)
Prazo: 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)
Prazo: 30 days

Quantified during mechanical ventilation.

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

Quantified during mechanical ventilation.

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

Quantified during mechanical ventilation.

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

Quantified during mechanical ventilation.

30 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2024

Conclusão Primária (Estimado)

30 de setembro de 2026

Conclusão do estudo (Estimado)

30 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

8 de julho de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de julho de 2024

Primeira postagem (Real)

15 de julho de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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