- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07755969
Evaluation of a Specialised Tracheostomy Team for the Management of Patients With a Tracheostomy Cannula in a Belgium General Hospital: A Retrospective Study.
Management of Patients With a Tracheostomy Cannula by a Specialised Team in a Belgium General Hospital: A Retrospective Study
Patients admitted to intensive care units (ICUs) frequently require prolonged mechanical ventilation. Difficulties in weaning from mechanical ventilation represent an important indication for performing a tracheotomy, which involves creating a temporary opening in the trachea into which a cannula is inserted. This procedure is often confused with a tracheostomy, in which a permanent stoma is created.
Tracheotomy offers several clinical benefits, including increased patient comfort, reduced sedation requirements, decreased work of breathing, improved oral hygiene, a lower risk of ventilator-associated pneumonia, and lower mortality. With the increasing use of the percutaneous technique, the procedure is increasingly performed by intensivists. Consequently, the number of patients with a tracheostomy cannula in the ICU is increasing.
Following clinical stabilisation, these patients are transferred to inpatient wards throughout the hospital according to their underlying pathology. However, nurses working on these wards encounter tracheostomy-related care less frequently, which may include suctioning, wound care, cannula care, and decannulation.
Despite the availability of clinical procedures and protocols, a lack of knowledge, skills, and confidence in providing safe tracheostomy-related care persists. This increases the risk of complications such as cannula obstruction, infection, hypoxaemia, dislodgement, and bleeding. To address this issue, specialised multidisciplinary tracheostomy teams are increasingly being implemented.
The aim of this retrospective study is to answer the following research question: What is the impact of a specialised multidisciplinary tracheostomy team on clinical outcomes in hospitalised patients with a tracheostomy cannula?
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lisa Christiaens, MSc
- 전화번호: +3237606060
- 이메일: brecht.serraes@vitaz.be
연구 장소
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Oost-Vlaanderen
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Sint-Niklaas, Oost-Vlaanderen, 벨기에, 9100
- Vitaz
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연락하다:
- Brecht Serraes, Doctor
- 전화번호: +3237602039
- 이메일: brecht.serraes@vitaz.be
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수석 연구원:
- Brecht Serraes, Doctor
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Hospitalisation between 2010 and 2026 in VITAZ (general hospital, Belgium)
- Age ≥18 years.
- Presence of a tracheostomy cannula (tracheotomy, permanent tracheostomy, or laryngectomy).
- Curative and palliative patients will be included.
Exclusion Criteria:
- Ambulatory care
- Day hospitalisation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Pre-intervention cohort: Before specialised tracheostomy team implementation
Hospitalised patients with a tracheostomy cannula who received routine clinical care before the establishment and implementation of the specialised multidisciplinary tracheostomy team.
This cohort serves as the pre-intervention comparison group.
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Post-intervention cohort: After specialised tracheostomy team implementation
Hospitalised patients with a tracheostomy cannula who received care after the establishment and implementation of the specialised multidisciplinary tracheostomy team.
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The intervention of interest is the implementation of the specialised multidisciplinary tracheostomy team, which provides structured, team-based care for patients with a tracheostomy cannula.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tracheo(s)tomy-related ICU readmission
기간: through study completion, an average of 1 year
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Occurrence of readmission to the intensive care unit due to tracheo(s)tomy cannula-related problems.
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through study completion, an average of 1 year
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Successful decannulation
기간: through study completion, an average of 1 year
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Successful decannulation of the tracheo(s)tomy cannula according to predefined criteria derived from the literature.
The proportion of patients achieving successful decannulation will be compared between the pre-intervention and post-intervention cohorts.
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through study completion, an average of 1 year
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Tracheo(s)tomy-related complications
기간: through study completion, an average of 1 year
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Occurrence of predefined canulla-related complications, including airway obstruction, wound infection, bleeding, ... .
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through study completion, an average of 1 year
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Performance of FEES
기간: through study completion, an average of 1 year
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Performance of a fibreoptic endoscopic evaluation of swallowing (FEES) during hospitalisation.
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through study completion, an average of 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total hospital length of stay
기간: through study completion, an average of 1 year
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From hospital admission until hospital discharge
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through study completion, an average of 1 year
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Use of high-flow oxygen therapy or active humidification
기간: through study completion, an average of 1 year
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Use of high-flow oxygen therapy and/or active humidification during hospitalisation.
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through study completion, an average of 1 year
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Time to tracheo(s)tomy
기간: through study completion, an average of 1 year
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Number of days from hospital admission to the performance of the tracheo(s)tomy.
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through study completion, an average of 1 year
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Time from ICU admission to transfer to an inpatient ward
기간: through study completion, an average of 1 year
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Duration of intensive care unit stay before transfer to an inpatient ward.
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through study completion, an average of 1 year
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Length of ICU stay following canulla-related readmission
기간: through study completion, an average of 1 year
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Duration of intensive care unit stay following readmission due to cannula-related problems.
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through study completion, an average of 1 year
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Mortality due to cannulla-related complications
기간: through study completion, an average of 1 year
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Occurrence of death attributable to tracheo(s)tomy- or cannula-related complications.
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through study completion, an average of 1 year
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Use of a speaking valve
기간: through study completion, an average of 1 year
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Occurrence and use of a speaking valve during hospitalisation.
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through study completion, an average of 1 year
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Responsible medical discipline
기간: through study completion, an average of 1 year
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Location and discipline responsible for tracheostomy placement.
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through study completion, an average of 1 year
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Ninan A, Grubb LM, Brenner MJ, Pandian V. Effectiveness of interprofessional tracheostomy teams: A systematic review. J Clin Nurs. 2023 Oct;32(19-20):6967-6986. doi: 10.1111/jocn.16815. Epub 2023 Jul 3.
- Speed L, Harding KE. Tracheostomy teams reduce total tracheostomy time and increase speaking valve use: a systematic review and meta-analysis. J Crit Care. 2013 Apr;28(2):216.e1-10. doi: 10.1016/j.jcrc.2012.05.005. Epub 2012 Aug 27.
- Parker V, Giles M, Shylan G, Austin N, Smith K, Morison J, Archer W. Tracheostomy management in acute care facilities--a matter of teamwork. J Clin Nurs. 2010 May;19(9-10):1275-83. doi: 10.1111/j.1365-2702.2009.03155.x. Epub 2010 Mar 18.
- Holmes TR, Cumming BD, Sideris AW, Lee JW, Briggs NE, Havas TE. Multidisciplinary Tracheotomy Teams: An Analysis of Patient Outcomes and Resource Allocation. Ear Nose Throat J. 2019 Apr-May;98(4):232-237. doi: 10.1177/0145561319840103. Epub 2019 Apr 2.
- Garrubba M, Turner T, Grieveson C. Multidisciplinary care for tracheostomy patients: a systematic review. Crit Care. 2009;13(6):R177. doi: 10.1186/cc8159. Epub 2009 Nov 6.
- Brenner MJ, Pandian V, Milliren CE, Graham DA, Zaga C, Morris LL, Bedwell JR, Das P, Zhu H, Lee Y Allen J, Peltz A, Chin K, Schiff BA, Randall DM, Swords C, French D, Ward E, Sweeney JM, Warrillow SJ, Arora A, Narula A, McGrath BA, Cameron TS, Roberson DW. Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership. Br J Anaesth. 2020 Jul;125(1):e104-e118. doi: 10.1016/j.bja.2020.04.054. Epub 2020 May 23.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- EC26004 (기타 식별자: VITAZ, commissie voor medische ethiek)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
연구 데이터/문서
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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