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

Phase 2

Recruiting

• Conditions: Esophageal carcinoma

• Registration Number: JPRN-jRCT1042230119
• Lead Sponsor: Kanda Mitsuro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-21
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of pneumonia or atelectasis of grade II or higher of the Clavien-Dindo classification occurring by postoperative day 16

Secondary Outcome Measures

Name	Time	Method
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.)<br>postoperative atelectasis rate (all grades of Clavien-Dindo classification)<br>percentage of cricothyroid punctures<br>Respiratory function tests<br>Acapella Choice usage<br>arterial blood gas analysis<br>Serum sialylated carbohydrate antigen KL-6<br>perioperative antibiotic use (total number of days used postoperatively, including prophylactic antibiotics)<br>duration of expectorant use<br>independent scoring for pneumonia<br>days on oxygen (total number of days on oxygen)<br>grip strength, Short Physical Performance Battery