Intermittent Positive Pressure Breathing Versus Incentive Spirometry After Thoracic Surgery
The Effects of Intermittent Positive Pressure Breathing and Incentive Spirometry on Postoperative Pulmonary Complications and Lung Volume in Patients Undergoing Thoracic Surgery: A Randomized Controlled Trial
This randomized controlled pilot study will compare intermittent positive pressure breathing (IPPB) with incentive spirometry (IS) in adult patients undergoing thoracic surgery. The study aims to evaluate the effects of these two postoperative pulmonary rehabilitation interventions on lung volume recovery, respiratory muscle strength, oxygenation, pulmonary complications, and overall postoperative recovery. Participants will be randomly assigned to either the IPPB group or the IS group. Assessments will be performed before surgery and after the intervention period.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This is a single-center, randomized controlled pilot study conducted at Fu Jen Catholic University Hospital. A total of 30 adult patients undergoing thoracic surgery will be enrolled and randomly assigned to one of two intervention groups: intermittent positive pressure breathing (IPPB) or incentive spirometry (IS).
Before surgery, participants will undergo baseline assessments including blood sampling, lung volume measurement, chest X-ray, respiratory muscle strength assessment, and pulmonary function evaluation. After surgery, participants will receive the assigned pulmonary rehabilitation intervention from postoperative day 0 through postoperative day 3.
Participants assigned to the IS group will perform supervised slow and deep inspirations using an incentive spirometer 3 to 4 times per day, with three sets of 10 breaths per session. Participants will also be encouraged to practice independently while awake. Participants assigned to the IPPB group will receive intermittent positive pressure breathing as the postoperative lung expansion intervention according to the study protocol.
Follow-up assessments will be performed after the intervention period. Outcomes will include changes in lung volume; maximal inspiratory and expiratory pressures; physiologic parameters including heart rate, respiratory rate, and blood pressure; chest X-ray findings; pulmonary function; arterial blood gas measurements; peripheral oxygen saturation; dyspnea; pain; and postoperative pulmonary complications. Blood samples will also be collected to evaluate C-reactive protein as an indicator of postoperative inflammatory response.
The study is designed to evaluate the feasibility of the study procedures and to obtain preliminary estimates of treatment effects that may be used to inform the sample size and design of a future definitive randomized controlled trial.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Hui-Wen Hsu, M.S.
- 전화번호: 23426 +886-2-8512-8888
- 이메일: 76wwocat@gmail.com
연구 연락처 백업
- 이름: Shu-Hung Kuo, M.D.
- 전화번호: 23426 +886-2-8512-8888
- 이메일: A05511@mail.fjuh.fju.edu.tw
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide written informed consent.
- Adults aged 18 years or older.
- Undergoing thoracic surgery.
- Considered eligible by a specialist physician to participate in pulmonary rehabilitation training.
Exclusion Criteria:
- Unable to cooperate with the study procedures.
- Untreated pneumothorax.
- Severe hemodynamic instability.
- Active hemoptysis or gastrointestinal bleeding.
- Intracranial pressure greater than 15 mmHg.
- Recent facial, oropharyngeal, or cranial surgery or injury.
- Tracheoesophageal fistula.
- Recent esophageal surgery.
- Nausea or vomiting.
- Pulmonary bullae identified on imaging.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Intermittent Positive Pressure Breathing Group
Participants assigned to this group will receive intermittent positive pressure breathing (IPPB) as the postoperative lung expansion intervention from postoperative day 0 through postoperative day 3. |
Intermittent positive pressure breathing will be provided as a postoperative lung expansion intervention from postoperative day 0 through postoperative day 3. |
|
활성 비교기: Incentive Spirometry Group
Participants assigned to this group will perform postoperative lung expansion training using incentive spirometry from postoperative day 0 through postoperative day 3. |
Participants will perform incentive spirometry from postoperative day 0 through postoperative day 3 under therapist supervision 3 to 4 times per day. Each supervised session will consist of 3 sets of 10 slow, deep inspirations, with a 2- to 3-second inspiratory hold. Participants will also be encouraged to practice independently while awake. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Lung Volume
기간: Baseline (preoperative) and postoperative day 3
|
Change in lung volume, including tidal volume and minute ventilation, measured using a respiratory volume measurement device. |
Baseline (preoperative) and postoperative day 3
|
|
Change in Maximal Inspiratory Pressure
기간: Baseline (preoperative) and postoperative day 3
|
Change in maximal inspiratory pressure (MIP) measured using a respiratory pressure measurement device to assess inspiratory muscle strength. |
Baseline (preoperative) and postoperative day 3
|
|
Change in Maximal Expiratory Pressure
기간: Baseline (preoperative) and postoperative day 3
|
Change in maximal expiratory pressure (MEP) measured using a respiratory pressure measurement device to assess expiratory muscle strength. |
Baseline (preoperative) and postoperative day 3
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in C-Reactive Protein
기간: Baseline (preoperative) and postoperative day 3
|
Change in serum C-reactive protein (CRP) concentration as an indicator of postoperative inflammatory response. |
Baseline (preoperative) and postoperative day 3
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Shu-Hung Kuo, M.S., Fu Jen Catholic University Hospital
간행물 및 유용한 링크
일반 간행물
- Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
- Ludwig C, Angenendt S, Martins R, Mayer V, Stoelben E. Intermittent positive-pressure breathing after lung surgery. Asian Cardiovasc Thorac Ann. 2011 Feb;19(1):10-3. doi: 10.1177/0218492310394664.
- Agostini P, Naidu B, Cieslik H, Steyn R, Rajesh PB, Bishay E, Kalkat MS, Singh S. Effectiveness of incentive spirometry in patients following thoracotomy and lung resection including those at high risk for developing pulmonary complications. Thorax. 2013 Jun;68(6):580-5. doi: 10.1136/thoraxjnl-2012-202785. Epub 2013 Feb 21.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- FJUH115610
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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