Vibration positive expiratory pressure therapy in the perioperative period for esophageal cancer

JRCT ID: jRCT1042230119

Registered date:21/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal carcinoma
• Date of first enrollment: 21/12/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Vibration positive expiratory pressure therapy in the perioperative period for esophageal cancer

Outcome(s)

• Primary Outcome: Percentage of pneumonia or atelectasis of grade II or higher of the Clavien-Dindo classification occurring by postoperative day 16

Secondary Outcome

Postoperative pneumonia rate (all grades of Clavien-Dindo classification and at least 2 points of The Utrecht Pneumonia scoring system by Karin Valkenet et al.)
postoperative atelectasis rate (all grades of Clavien-Dindo classification)
percentage of cricothyroid punctures
Respiratory function tests
Acapella Choice usage
arterial blood gas analysis
Serum sialylated carbohydrate antigen KL-6
perioperative antibiotic use (total number of days used postoperatively, including prophylactic antibiotics)
duration of expectorant use
independent scoring for pneumonia
days on oxygen (total number of days on oxygen)
grip strength, Short Physical Performance Battery

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients scheduled for minimally invasive esophagectomy for curatively resectable esophageal cancer
Patients with an ECOG performance status (PS) of 0, 1, or 2
Cases in which the patient's written consent has been obtained

Exclude criteria

Cases in which split surgery is performed
Tracheostomies and cases with permanent tracheal holes
Cases of emergency surgery
Cases with a history of thoracic radiotherapy
Cases with severe lung diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.)
Patients with a history of clinically problematic mental disorders or central nervous system disorders
Cases in which spirometry is not feasible.
Patients with a history of pneumothorax
Cases in which the principal investigator or physician in charge judges that the patient is not suitable to participate in this study

Related Information

• Primary Sponsor: Kanda Mitsuro