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Bubble CPAP Team-Based Care Strategy Feasibility Trial

2026년 5월 20일 업데이트: Yale University

Feasibility Trial of a Bubble Continuous Positive Airway Pressure Team-Based Care Strategy in Pakistan

The goal of this pre/post, effectiveness-implementation feasibility trial is to learn if a larger, multisite trial of a bubble continuous positive airway pressure (bCPAP) team-based care strategy is feasible in children with severe pneumonia. The main questions it aims to answer are:

Is a future, larger, multisite trial of a bCPAP team-based care strategy feasible? Is the bCPAP team-based care strategy feasible and acceptable to clinicians and caregivers?

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

This study is a single-group, pre-post implementation study designed to evaluate the feasibility and preliminary effectiveness of a team-based care strategy to improve delivery of bubble continuous positive airway pressure (bCPAP) among children presenting with severe pneumonia to participating hospitals.

The study uses a repeated cross-sectional design in which distinct cohorts of participants are enrolled during a 4-month pre-implementation period and a 4-month post-implementation period based on timing of emergency department presentation. A unit-level implementation strategy is introduced between these periods, and outcomes are compared across time rather than between concurrently assigned groups.

The intervention consists of an adaptable, team-based care implementation strategy to support delivery of bCPAP in routine clinical care. Components may include provider education, preparation of local champions, training of clinical staff, caregiver education and engagement, and ongoing supportive supervision. The strategy may be refined over time based on local context and implementation needs. bCPAP is already available and used in participating units; this study does not involve introduction of a new device but instead focuses on improving the uptake, fidelity, and quality of its use within standard care.

The study population includes pediatric participants meeting criteria for severe pneumonia, as well as caregivers and clinicians who contribute survey and qualitative interview data related to implementation outcomes. Quantitative and qualitative data are collected to evaluate feasibility, acceptability, implementation fidelity, and clinical outcomes, including follow-up after presentation.

The primary objective is to assess feasibility of progression to a larger trial using predefined criteria. Secondary objectives include evaluating feasibility and acceptability of the implementation strategy and characterizing implementation processes in the post-implementation period.

Participants will:

  • Be enrolled during either the pre-implementation or post-implementation period based on timing of hospital admission
  • Have relevant clinical information obtained through medical record review
  • Undergo a study-specific physical examination, as applicable
  • Have their caregivers complete surveys assessing experiences, perceptions of care, and/or clinical outcomes
  • Have treating clinicians complete surveys assessing implementation outcomes such as feasibility, acceptability, and usability
  • Receive clinical care that may include bubble continuous positive airway pressure (bCPAP) delivered as part of routine practice
  • Be cared for in units implementing an adaptable, team-based bCPAP care strategy, which may include provider education, local champion engagement, training activities, and supportive supervision, and may be refined over time based on implementation needs
  • Be invited (subset of caregivers and clinicians) to participate in qualitative interviews to assess feasibility, acceptability, and experiences with the care strategy
  • Be followed for 14 days after initial emergency department presentation to assess clinical outcomes, including mortality (via medical record review and/or caregiver contact, as applicable)
  • Contribute data that will be compared across pre-implementation and post-implementation periods involving different participant cohorts

연구 유형

중재적

등록 (추정된)

95

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 파키스탄
      • Karachi, 파키스탄
        • Aga Khan University Hospital
        • 연락하다:
      • Karachi, 파키스탄
        • Abbasi Shaheed Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

Pediatric participants:

  • Provision of signed and dated informed consent form by legal guardian (as determined by local policies and laws)
  • Stated willingness (by guardian) to comply with all study procedures and availability for the duration of the study
  • Presentation to the Emergency Department with cough or difficulty breathing (as documented in triage notes)
  • Meeting the World Health Organization definition for severe pneumonia: Exhibiting severe respiratory distress (clinical respiratory score of at least 8) OR Exhibiting hypoxemia (SpO2<90%) OR Exhibiting a general danger sign (Vomiting everything (as reported by child's caregiver), Inability to feed (as reported by child's caregiver), Seizure/convulsion (as documented in medical chart or reported by child's caregiver), Reduced level of consciousness (as assessed at screening)
  • In addition, exhibiting either:
  • Severe respiratory distress (clinical respiratory score of at least 8)
  • Hypoxemia (SpO2<90%)

Physicians and nurses:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, over 18 years of age
  • Directly cared for any child receiving bCPAP therapy during the post-implementation period of the study

Caregivers:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, any age
  • Primary caregiver at bedside of a child enrolled in the post-implementation period of our study.

Exclusion Criteria:

Pediatric participants:

  • Known congenital heart disease
  • Asthma
  • Upper airway obstruction
  • Tracheostomy

Physicians and nurses:

  • Temporarily rotating through the department, ward, or unit

Caregivers:

  • Does not speak Urdu or English fluently

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Participants cared for under bCPAP team-based care strategy
This single arm includes pediatric participants and their caregivers, nurses, and physicians enrolled during pre-implementation and post-implementation periods based on timing of hospital presentation. A team-based, unit-level bCPAP care implementation strategy is introduced between periods and may include provider education, local champion engagement, training activities, and supportive supervision, with potential refinement over time. Outcomes are compared across pre- and post-implementation cohorts, which consist of different participants.
행동: bCPAP team-based care strategy
This intervention consists of an adaptable, team-based implementation strategy to support delivery of bubble continuous positive airway pressure (bCPAP) in routine clinical care. The strategy is implemented at the unit level and may include provider education, preparation of local champions, training of clinical staff, caregiver education and engagement, and ongoing supportive supervision. These components are designed to improve provider knowledge, skills, teamwork, communication, and caregiver understanding related to bCPAP use. The strategy may be refined over time based on local context and implementation needs. The intervention does not assign bCPAP directly but seeks to enhance the uptake, fidelity, and quality of its use within standard clinical practice. bCPAP is already available and used in participating units; this intervention does not involve introduction of a new device but rather focuses on improving the delivery and quality of existing care.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of a Larger Trial
기간: From enrollment through completion of 14-day follow-up
Feasibility of a larger trial of the bCPAP team-based care strategy, as assessed using predefined trial progression criteria, including recruitment and consent rates, completeness and quality of effectiveness outcomes data, and completeness and quality of implementation outcomes data, with evaluation against prespecified benchmarks defined in the study protocol. This is a composite measure defined as: if certain criteria are met, the study will proceed to a larger trial.
From enrollment through completion of 14-day follow-up

2차 결과 측정

결과 측정
측정값 설명
기간
Feasibility of the bCPAP Team-Based Care Strategy Among Caregivers
기간: Within 14 days after emergency department presentation during the post-implementation period
Assessed using qualitative interviews with caregivers, with thematic analysis of perceived feasibility, including barriers and facilitators to participation in bCPAP care processes.
Within 14 days after emergency department presentation during the post-implementation period
Implementation Fidelity to the bCPAP Team-Based Care Strategy Among Clinicians
기간: Throughout the post-implementation period (4 months) during delivery of the implementation strategy
Assessed by tracking implementation activities, including frequency of clinician champion meetings, frequency of implementation data dissemination, and clinician attendance at bCPAP training sessions.
Throughout the post-implementation period (4 months) during delivery of the implementation strategy
Caregiver Engagement With bCPAP Educational Components
기간: Within 24 hours of bCPAP therapy initiation in the post-implementation period
Assessed as the proportion of caregivers who view a bCPAP educational video during the clinical encounter.
Within 24 hours of bCPAP therapy initiation in the post-implementation period
Overall Feasibility and Acceptability of the bCPAP Team-Based Care Strategy
기간: Throughout the post-implementation period (4 months) during delivery of the implementation strategy
Assessed as a composite evaluation of implementation outcomes, including caregiver-reported feasibility and acceptability (qualitative interviews), implementation fidelity among clinicians, and caregiver engagement with educational components. These domains will be considered together to characterize the overall feasibility and acceptability of the bCPAP team-based care strategy in routine clinical practice using a predefined framework to integrate findings across domains.
Throughout the post-implementation period (4 months) during delivery of the implementation strategy

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Yale University

협력자

National Heart, Lung, and Blood Institute (NHLBI)

수사관

  • 수석 연구원: Nadir Ijaz, MD, MHS, Yale University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2028년 4월 1일

기본 완료 (추정된)

2028년 4월 1일

연구 완료 (추정된)

2029년 3월 1일

연구 등록 날짜

최초 제출

2026년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 6월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 20일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2000042882
  • 1K23HL181402-01A1 (기타 식별자: Pending NIH grant application supporting this study)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Individual participant data (IPD) that underlie the results reported in publications will be shared, after de-identification, in accordance with applicable ethical, legal, and regulatory requirements.

IPD 공유 기간

The data will be made available immediately at the time of publication of the results. Data will be available for at least 5 years.

IPD 공유 액세스 기준

Data will be shared via an open access repository.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다