High Flow Nasal Cannula After Esophagectomy (OSSIGENA1V)

July 27, 2023 updated by: Cristian Deana

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Udine, Italy, 33100
        • Recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale
        • Contact:
          • CRISTIAN DEANA, MD
          • Phone Number: +390432552410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFNC
Administration of high flow nasal oxygen after extubation for 48 hours
Device: AIRVO2
APPLICATION OF HIGH FLOW NASAL CANNULA OXYGEN FOR 48 HOURS AFTER ESOPHAGECTOMY
Other: STANDARD OXYGEN
Administration of oxygen through standard devices (nasal cannulae, venturi mask, none)
Other: STANDARD CARE
APPLICATION OF OXYGEN THROUGH STANDARD CARE FOR 48 HOURS AFTER ESOPHAGECTOMY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POST-OPERATIVE PULMONARY COMPLICATIONS
Time Frame: within 30 days after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CARDIO-VASCULAR COMPLICATIONS
Time Frame: within 30 days after surgery
Describe the frequency of myocardial infarction, pulmonary edema, cardiac arrest, pulmonary embolism, deep venous thrombosis, stroke, pericardtis
within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cristian Deana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSSIGENA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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