이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

소아 기관절개술 및 가정 인공호흡기 모집단의 시뮬레이션 교육

2026년 11월 6일 업데이트: Jennifer Henningfeld, Medical College of Wisconsin

The investigators will develop, refine and pilot a highly-realistic simulation program that will allow caregivers opportunities to manage critical situations as it pertains to a medically complex child dependent on tracheostomy with or without home ventilation. The investigators hope to demonstrate that the use of highly realistic simulation training will improve hospital utilization as caregivers will have a more realistic understanding of clinical and equipment-related emergencies that may occur outpatient.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

The investigators propose a prospective randomized control trial evaluating the use of simulation to prepare caregivers for the discharge of children dependent on respiratory technology. All caregivers of children who are (1) inpatient with a newly placed tracheostomy tube and (2) anticipated to start discharge teaching after the first date of Institutional Review Board (IRB) approval will be enrolled, regardless of home ventilator need. Caregivers with prior experience caring for tracheostomies within the last 10 years will be excluded. Estimated sample size is 60 caregivers (trainees) (2 trained caregivers anticipated per child). Trainees must be able to speak and read English.

All trainees will be randomized by child (up to 4 per child) into one of three arms (Figure 1), stratified by the need for invasive home ventilation and randomized in blocks of four. All trainees will complete our current state of education including bedside education provided by Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) nursing staff and a formal classroom-based skills class (either a 'tracheostomy-only' or a 'tracheostomy/home ventilator' class) taught by a Children's Hospital of Wisconsin (CHW) Tracheostomy and Home Ventilator respiratory therapist or durable medical equipment company (DME) respiratory therapist, and an individual scenario-based review of equipment and skills workshop with a CHW Tracheostomy and Home Ventilator Respiratory Therapist.

In addition to the current state of education, the active study group will also undergo highly realistic simulation. This involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. The active control will undergo low-fidelity simulation that approximates the highly realistic clinical scenarios except with the use of a low-fidelity doll equipped with a tracheostomy and without the audiovisual inputs. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the simulation instructor. After the simulation, participants will be debriefed by the instructor, who will use a tape of their session as a teaching tool.

Commonly encountered emergent outpatient problems to be simulated include 1) obstructed tracheostomy tube leading to the need for cardiopulmonary resuscitation; 2) bleeding from the tracheostomy tube; 3) acute desaturation and/or bradycardia; and 4) accidental decannulation. If invasive home ventilation is anticipated, ventilator alarm troubleshooting for high pressure alarms, low minute ventilation alarms, auto-cycling of the ventilator and water in the tubing will be included in the simulation.

All trainees will undergo a teach-back session with a CHW Tracheostomy and Home Ventilator Program respiratory therapist during which essential skills and responses to clinical situations are assessed. If a trainee passes this session, the respiratory therapist has determined that they have met criteria to move onto independent care sessions and the trainees have acquired the trach and home ventilator knowledge to provide care in the home. If a trainee fails this teach-back session, the information failed will be reviewed and the family will repeat the teach-back session until they pass and then move into independent care sessions. Independent care sessions are practical demonstrations of all skills needed to take care of the child at home. Independent care sessions are repeated until all skills have been passed. Teach-back and independent care sessions are part of the current state of education.

연구 유형

중재적

등록 (실제)

64

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • Wisconsin
      • Wauwatosa, Wisconsin, 미국, 53226
        • Children's Hospital of Wisconsin

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
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Anticipated count of 90 participants includes 30 patients and 60 caregivers (2 per patient). Caregivers are the primary subjects, and patients are enrolled so the investigators can use their medical records.

Caregivers:

Inclusion Criteria

  • Must be able to read and speak English
  • Caring for a patient with a tracheostomy being discharged from the NICU/PICU for the first time

Exclusion Criteria

- Can not have cared for a child with a tracheostomy in the last 10 years

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control

No intervention, the same as the current state of education. Caregivers will still complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.

실험적: Active study

In addition to the current state of education, the active study group will undergo highly realistic simulation. This involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. Caregivers will complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.

Simulation involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. The simulation will last approximately 2 hours and will end with reviewing the taped session as part of debriefing. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the same simulation instructor.

활성 비교기: Active control

In addition to the current state of education, the active control will undergo low-fidelity simulation that approximates the highly realistic clinical scenarios except with the use of a low-fidelity doll equipped with a tracheostomy and without the audiovisual inputs. If home invasive ventilation is anticipated, a home ventilator will be used. Caregivers still complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.

Simulation involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. The simulation will last approximately 2 hours and will end with reviewing the taped session as part of debriefing. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the same simulation instructor.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Teach-back session performance
기간: Within 4 weeks of hospital discharge

Difference in Teach-back performance between active study and control groups. Measured from 0-24, with higher scores being better.

Within 4 weeks of hospital discharge
Independent Care session performance
기간: Within 4 weeks of hospital discharge

Independent Care performance between active study and control groups.

Within 4 weeks of hospital discharge
Hospital length of stay
기간: First teaching session to discharge, an average of 4 weeks

Difference in hospital length of stay between active study and active control groups. Measured from 0-7, with higher scores being better.

First teaching session to discharge, an average of 4 weeks
Phone Calls
기간: 1 year after initial discharge

Difference in number of Phone Calls (from participants to medical providers/home care company) between active and control groups.

1 year after initial discharge
Number of Hospital Re-admissions/Emergency Room (ER) visits
기간: 1 year after initial discharge

Difference in the number of Hospital Re-admissions/ER visit counts between active and control groups.

1 year after initial discharge

2차 결과 측정

결과 측정
측정값 설명
기간
Quality of discharge teaching scores
기간: Within 48 hours of initial hospital discharge

Quality of Discharge Teaching Scale measured on day of discharge; scale of 0 to 10; very high/very low scores indicate stronger opinions

Within 48 hours of initial hospital discharge
Caregiver post-discharge coping scores
기간: Scale administered 24 hours after discharge and about 1 month after discharge

Post Discharge Coping Difficulty Scale administered 24 hours after discharge and at first Tracheostomy/Home Ventilator clinic visit; scale of 0 to 10; very high/very low scores indicate stronger opinions

Scale administered 24 hours after discharge and about 1 month after discharge

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Jennifer Henningfeld, MD, Medical College of Wisconsin

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 (실제)

2017년 9월 22일

기본 완료 (추정된)

2028년 8월 25일

연구 완료 (추정된)

2028년 8월 25일

연구 등록 날짜

최초 제출

2019년 12월 16일

QC 기준을 충족하는 최초 제출

2020년 3월 11일

처음 게시됨 (실제)

2020년 3월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 6일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 979984

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .