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NCT05718284 Clinical Trial

High Flow Nasal Cannula After Esophagectomy

Esophageal Cancer Clinical Trial

— OSSIGENA1V  

Official title:
High Flow Nasal Cannula Oxygen Administration Versus Standard Care After Esophagectomy for Cancer: a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05718284
Other study ID # OSSIGENA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date January 2025

Study information
Verified date April 2023
Source Azienda Sanitaria-Universitaria Integrata di Udine
Contact CRISTIAN DEANA, MD
Phone +393333745660
Email CRISTIAN.DEANA@ASUFC.SANITA.FVG.IT
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the effect of HFNC versus standard oxygen administration after elective esophagectomy for cancer.

Recruitment information / eligibility
Status Recruiting
Enrollment 320
Est. completion date January 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - elective esophagectomy for cancer - METS=4 - AGE 18-85 - Written informed consent Exclusion Criteria: - ASA>3 - COPD= III stage according to GOLD criteria - FEV1<50% - EF<30% - NYHA>2 - BMI<17 or >35 Kg/m2 - CKD with eGFR<60 mL/min

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• AIRVO2
APPLICATION OF HIGH FLOW NASAL CANNULA OXYGEN FOR 48 HOURS AFTER ESOPHAGECTOMY
Other:
• STANDARD CARE
APPLICATION OF OXYGEN THROUGH STANDARD CARE FOR 48 HOURS AFTER ESOPHAGECTOMY

Locations
Country Name City State
Italy Azienda Sanitaria Universitaria Friuli Centrale Udine

Sponsors (1)
Lead Sponsor Collaborator
Cristian Deana

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Deana C, Vetrugno L, Stefani F, Basso A, Matellon C, Barbariol F, Vecchiato M, Ziccarelli A, Valent F, Bove T, Bassi F, Petri R, De Monte A. Postoperative complications after minimally invasive esophagectomy in the prone position: any anesthesia-related factor? Tumori. 2021 Dec;107(6):525-535. doi: 10.1177/0300891620979358. Epub 2020 Dec 15. — View Citation

Xia M, Li W, Yao J, Jin Y, Du G, Xu Q, Yi X, Nv X, Wu Y, He P, Wu W. A postoperative comparison of high-flow nasal cannula therapy and conventional oxygen therapy for esophageal cancer patients. Ann Palliat Med. 2021 Mar;10(3):2530-2539. doi: 10.21037/apm-20-1539. Epub 2021 Jan 21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary POST-OPERATIVE PULMONARY COMPLICATIONS Describe the frequency of PPC that include: pneumonia, pleural effusion, pneumothorax, atelectasis, ARDS, aspiration pneumonia, trachea-bronchial lesion, air leak within 30 days after surgery
Secondary CARDIO-VASCULAR COMPLICATIONS Describe the frequency of myocardial infarction, pulmonary edema, cardiac arrest, pulmonary embolism, deep venous thrombosis, stroke, pericardtis within 30 days after surgery
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