Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope
Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound
연구 개요
상세 설명
Linear endobronchial ultrasound (EBUS) now plays a crucial role in the diagnosis, staging, and treatment planning of lung cancer. Most centers perform linear EBUS via the oral route given the larger diameter of the bronchoscope used. However, the feasibility and the diagnostic accuracy of linear EBUS performed through the nose have not been reported. Furthermore, the two routes of insertion have never been compared in terms of patient satisfaction and comfort.
In order to compare the two routes of insertion, consecutive patients referred for a linear endobronchial ultrasound will be recruited. Participants will be randomized to either oral or nasal insertion. All participants will be sedated and will receive local anesthetics in a similar manner. After the procedure, patients will fill a questionnaire regarding their comfort and satisfaction with the procedure.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Quebec
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Québec, Quebec, 캐나다, G1V 4G5
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients older than 18 years of age
- patients referred for a first linear endobronchial ultrasound
Exclusion Criteria:
- Patients who previously underwent an EBUS
- Patients intubated with an endotracheal tube
- Patients under the age of 18
- Patients unable to provide informed consent
- Patients currently taking anticoagulants (therapeutic doses of intravenous or subcutaneous heparin, low-molecular weight heparins, direct thrombin inhibitors or other agents)
- Patients taking anti-platelet therapy other than aspirin (clopidogrel, ticagrelor, prasugrel). A period of 7 days off medication is required before participation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Nasal EBUS insertion
Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose.
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다른: Oral EBUS insertion
Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient comfort and satisfaction
기간: Two hours after endobronchial ultrasound
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Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.
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Two hours after endobronchial ultrasound
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physician's assessment of patient comfort
기간: Immediately after the procedure (within 10 minutes)
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Measured by a questionnaire using a 10-point Likert scale regarding patient comfort and procedural difficulties.
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Immediately after the procedure (within 10 minutes)
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Duration of endobronchial ultrasound procedure
기간: During the procedure
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Measured in minutes.
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During the procedure
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Total doses of sedation
기간: Immediately after the procedure (within 10 minutes)
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Total doses of each sedative used will be recorded.
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Immediately after the procedure (within 10 minutes)
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Occurence of pneumothorax, bleeding more than 50ml, oxygen desaturation to less than 90%, epistaxis, cardiac arrhythmia
기간: During the procedure and up to two hours after
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During the procedure and up to two hours after
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Proportion of adequate cytology specimens in each group
기간: Days after the procedure (results usually available within 10 days)
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Days after the procedure (results usually available within 10 days)
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Stéphane Beaudoin, MD, Laval University
- 수석 연구원: Simon Martel, MD, Laval University
- 수석 연구원: Antoine Delage, MD, Laval University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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