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- Essai clinique NCT07867548
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hui-Wen Hsu, M.S.
- Numéro de téléphone: 23426 +886-2-8512-8888
- E-mail: 76wwocat@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Shu-Hung Kuo, M.D.
- Numéro de téléphone: 23426 +886-2-8512-8888
- E-mail: A05511@mail.fjuh.fju.edu.tw
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Lung Volume
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in C-Reactive Protein
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shu-Hung Kuo, M.S., Fu Jen Catholic University Hospital
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FJUH115610
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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