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Aún no reclutaNCT07867548Registro de ClinicalTrials.gov

Intermittent Positive Pressure Breathing Versus Incentive Spirometry After Thoracic Surgery

Postoperative Pulmonary Complications · Thoracic Surgery

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
30 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

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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.
Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
Asignación al azar
Enmascaramiento
Sin enmascaramiento
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.

Other: Intermittent Positive Pressure Breathing

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.

Other: Incentive Spirometry

Intermittent Positive Pressure Breathing OTHER

Intermittent positive pressure breathing will be provided as a postoperative lung expansion intervention from postoperative day 0 through postoperative day 3.

Incentive Spirometry OTHER

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Change in Lung Volume

Plazo: Baseline (preoperative) and postoperative day 3

Change in lung volume, including tidal volume and minute ventilation, measured using a respiratory volume measurement device.

Change in Maximal Inspiratory Pressure

Plazo: Baseline (preoperative) and postoperative day 3

Change in maximal inspiratory pressure (MIP) measured using a respiratory pressure measurement device to assess inspiratory muscle strength.

Change in Maximal Expiratory Pressure

Plazo: Baseline (preoperative) and postoperative day 3

Change in maximal expiratory pressure (MEP) measured using a respiratory pressure measurement device to assess expiratory muscle strength.

Medidas secundarias

Change in C-Reactive Protein

Plazo: Baseline (preoperative) and postoperative day 3

Change in serum C-reactive protein (CRP) concentration as an indicator of postoperative inflammatory response.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (0)

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No hay centros indicados. Usa el contacto oficial del estudio.

Equipo y fechas

Patrocinador principal
Fu Jen Catholic University Hospital
Inicio del estudio
12 oct 2026 Estimado
Finalización primaria
31 jul 2027 Estimado
Finalización del estudio
31 jul 2027 Estimado
Primera publicación
9 oct 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Título oficial del estudio

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

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026