臨床研究等提出・公開システム

Survey on the Effect of CNAP (Continuous Negative Abdominal Pressure) in Maintaining Oxygenation after Liberation from Mechanical Ventilation

CNAP survey

Yamaguchi Takumi

Department of Anesthesia and Intensive Care, Japnanese Red Cross Aichi Medical Center Nagoya Daini Hospital

2-9, Myokencho, Showa-ku, Nagoya, Aichi 466-8650, Japan

tynmu148945@gmail.com

Yamaguchi Takumi

Department of Anesthesia and Intensive Care, Japnanese Red Cross Aichi Medical Center Nagoya Daini Hospital

2-9, Myokencho, Showa-ku, Nagoya, Aichi 466-8650, Japan

+81-8057185853

tynmu148945@gmail.com

Recruiting

Nov. 01, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

Patients who underwent cardiac surgery with cardiopulmonary bypass.
Patients who were weaned from invasive mechanical ventilation within one week after surgery.
At the time of invasive mechanical ventilation weaning, patients with a PaO2/FiO2 ratio > 200 and PEEP < 8 cmH2O.
Patients with a left ventricular ejection fraction > 20%.
Written informed consent for participation in this study has been obtained from the patient or a legally authorized representative.

Patients younger than 18 years of age at the time of consent.
Patients who have undergone surgical procedures involving abdominal incision and who have surgical wounds in the abdominal region.
Patients with skin lesions at the intended CNAP application site that make appropriate application difficult.
Patients who are pregnant or may be pregnant.
Patients in whom, due to physical characteristics or device limitations, the target continuous negative pressure cannot be stably maintained after CNAP application.
Patients for whom, at the time of liberation from invasive positive pressure ventilation (IPPV), noninvasive positive pressure ventilation (NPPV) was deemed medically necessary.

Both

Postoperative respiratory failure after cardiac surgery requiring cardiopulmonary bypass

In addition to standard therapy, CNAP will be applied using the extracorporeal positive and negative pressure ventilator TCV-100K (IMI Co., Ltd., Saitama, Japan).

Change in the PaO2/FiO2 ratio from the time of extubation to 24 hours after extubation

PaO2/FiO2 ratio and respiratory rate at 0, 6, 12, 18, and 24 hours after extubation
Rate of reintroduction of noninvasive positive pressure ventilation (NPPV) or invasive positive pressure ventilation (IPPV) by reintubation, and time to event
Incidence of skin complications at the CNAP application site

+81-528321121

Sept. 05, 2025

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