- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04729634
Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery (SOMBATA)
Background
Thoracic or abdominal surgeries are followed by a shorter or longer period of immobilization and after major surgery there is a higher risk of developing cardiorespiratory complications. To prevent these complications, the patient is encouraged to change position and exercise in bed, get out of bed as early and as much as possible after the operation and to breathe with or without aids. There is no general definition of early mobilization and may start within a few hours to a few days after surgery. There is currently a lack of knowledge nationally and internationally about when the mobilization starts and what it contains.
Many patients also receive breathing training in connection with the surgery. There is currently no consensus on which method is preferable for which groups of patients. There are similarities and differences in practice in the world regarding postoperative breathing training. There are studies that have mapped practice after primarily thoracic surgery but also abdominal surgery. However, there are no studies that have mapped when the prescribed breathing training starts after different types of operations.
The purpose of the study is to map when mobilization and breathing training starts after abdominal and thoracic surgery and what is then performed
Method The study will be carried out as a quality follow-up with mapping of practice. Patients ≥ 18 years of age who are undergoing a planned or acute open, keyhole or robot-assisted surgery, who are extubated and who breathe spontaneously will be included. Exclusion criteria are completed plastic, trauma, orthopedic or transplant surgery.
The material will be recruited from Swedish university hospitals and county hospitals for 20 days of surgery (Monday through Thursday) for five consecutive weeks.
Clinical benefit The study will mean that clinical practice is presented which, with regard to mobilization, is the first study ever that will present when this takes place and what is done and, with regard to breathing training, the first that shows when this training is initiated.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Västra Götaland
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Göteborg, Västra Götaland, 스웨덴, 41345
- Sahlgrenska University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ≥ 18 years of age
- undergoing a planned or acute open, laparoscopic or robot-assisted surgeon in the thorax or abdomen
- who are extubated within 24 h of surgery
- breathe spontaneously within 24 h of surgery
Exclusion Criteria:
- reconstructive-, trauma-, transplantation- or orthopedic surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Mobilization and breathing training
Usual clinical care
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Mobilization and breathing exercises according to clinical care
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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When mobilization starts after surgery
기간: Within 24 hours after surgery
|
Time from termination of anaesthesia to when mobilization starts, ie when the patients are sitting with the legs over the edge of the bed
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Within 24 hours after surgery
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Mobilization- Content
기간: Within 24 hours after surgery
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Content of the mobilization performed i.e. which level of mobilization (sitting on the edge of the bed, standing by the bed, sitting in a chair and walking) which is reached.
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Within 24 hours after surgery
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Mobilization- Duration
기간: Within 24 hours after surgery
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Duration of the mobilization performed, minutes
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Within 24 hours after surgery
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|
When any intervention with breathing exercises starts after surgery
기간: Within 24 hours after surgery
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Time from termination of anesthesia to when the breathing exercise starts
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Within 24 hours after surgery
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Breathing exercise- Content
기간: Within 24 hours after surgery
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Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.
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Within 24 hours after surgery
|
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Breathing exercise- Intensity
기간: Within 24 hours after surgery
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Intensity of breathing exercise prescribed, sessions/time.
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Within 24 hours after surgery
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 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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