Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics
Open Abdomen · Mechanical Ventilation
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 18 Estimado
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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
Patients who underwent an abdominal surgery and had the abdomen remain open are called to have an "open abdomen". To limit the risk of further widening of their wounds, surgeons can use AbClo, which is a non-invasive abdominal binding device, to keep the abdominal wall together (i.e., approximate the fascia). However, as the device also compresses on the abdomen and adjacent lungs, this study aims:
- To assess whether the abdominal binding device causes changes in the pressure compressing the lungs, the lung volume, and the function of the lungs.
- To assess whether adjusting the breathing machine can mitigate such negative changes.
Participants will already be on the abdominal binding device when joining the study. Measurements on various aspects of the lung function (including its physical properties and capability to oxygenate the blood) will be done before and after adjustment of the abdominal binding device to the pressure (measured in the device itself) recommended by the manufacturer, as well as after the surgery to close the abdomen.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Adult patients aged 18 years or older
- Patients admitted to an ICU
- Patients with postoperative abdominal surgery with open abdomen
- Patients treated with AbClo device
- Patients intubated and mechanically ventilated
- Patients treated with intravenous sedation with a sedation-agitation scale score of 1-3
Exclusion Criteria:
- Transient criteria: Patients with severe hemodynamic instability, defined systolic blood pressure less than 75 mmHg or mean arterial pressure less than 60 mmHg despite vasopressor use
- Transient criteria: Patients with severe bleeding diathesis, defined as the latest platelet count less than 20 · 109/L, or the latest INR higher than 2.0
- Patients with concurrent injuries to upper gastrointestinal tract that would preclude esophageal balloon insertion
- Patients with bronchopleural fistula
- Patients with measured and uncontrolled increased intracranial pressure
Población del estudio
Adult patients admitted the ICU with open abdomen treated with AbClo device, and undergoing mechanical ventilation
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Abdominal fascial approximation device
All patients are already on the device before starting the study
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Changes in End-expiratory Transpulmonary Pressure
Plazo: On the day of enrolment and on the day of surgery to close the abdomen
Calculated by the difference between airway pressure and the value measured by an esophageal catheter at the end of expiration. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, after the adjustment, and again after the surgery to close the abdomen.
Medidas secundarias
Changes in Lung Volume
Plazo: On the day of enrolment
Measured by a ventilator capable of measuring end-expiratory lung volume, using a breath-in-breath-out method. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, and again after the adjustment.
Changes in oxygenation function
Plazo: On the day of enrolment and on the day of surgery to close the abdomen
Determined by the partial pressure of oxygen and PaO₂/FiO₂ ratio from arterial blood gas. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, after the adjustment, and again after the surgery to close the abdomen.
Response in End-expiratory Transpulmonary Pressure to PEEP Increase
Plazo: On the day of enrolment
In participants with negative end-expiratory transpulmonary pressure with clinically set PEEP, under the supervision of the clinical team in the ICU, PEEP will be titrated up until until zero or positive values are restored. Responses to the titration will be recorded.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
St. Michael's HospitalToronto, Ontario, CanadaReclutando
Equipo y fechas
- Patrocinador principal
- Unity Health Toronto
- Inicio del estudio
- 10 jun 2025 Real
- Finalización primaria
- 2027-06 Estimado
- Finalización del estudio
- 2027-06 Estimado
- Primera publicación
- 4 sept 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics (AbClo-Resp)
Consulta a Wellness Clinical Research
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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