High Flow Nasal Cannula After Esophagectomy

NCT ID: NCT05718284

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer Postoperative Pulmonary Atelectasis Postoperative Pneumonia Postoperative Pneumothorax Postoperative Infection of Incision Postoperative Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HFNC

Administration of high flow nasal oxygen after extubation for 48 hours

Group Type EXPERIMENTAL

AIRVO2

Intervention Type DEVICE

APPLICATION OF HIGH FLOW NASAL CANNULA OXYGEN FOR 48 HOURS AFTER ESOPHAGECTOMY

STANDARD OXYGEN

Administration of oxygen through standard devices (nasal cannulae, venturi mask, none)

Group Type OTHER

STANDARD CARE

Intervention Type OTHER

APPLICATION OF OXYGEN THROUGH STANDARD CARE FOR 48 HOURS AFTER ESOPHAGECTOMY

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AIRVO2

APPLICATION OF HIGH FLOW NASAL CANNULA OXYGEN FOR 48 HOURS AFTER ESOPHAGECTOMY

Intervention Type DEVICE

STANDARD CARE

APPLICATION OF OXYGEN THROUGH STANDARD CARE FOR 48 HOURS AFTER ESOPHAGECTOMY

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cristian Deana

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cristian Deana

MEDICAL doctor, Anesthesiologist and Critical Care Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azienda Sanitaria Universitaria Friuli Centrale

Udine, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

CRISTIAN DEANA, MD

Role: CONTACT

+393333745660

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

CRISTIAN DEANA, MD

Role: primary

+390432552410

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33323061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33548991 (View on PubMed)

Deana C, Vecchiato M, Azzolina D, Turi S, Boscolo A, Pistollato E, Skurzak S, Amici O, Priolo S, Tonini S, Foti LS, Taddei E, Aceto P, Martino A, Ziccarelli A, Cereser L, Andreutti S, De Carlo S, Lirussi K, Barbariol F, Cammarota G, Polati E, Forfori F, Corradi F, Patruno V, Navalesi P, Maggiore SM, Lucchese F, Petri R, Bassi F, Romagnoli S, Bignami EG, Vetrugno L; Ossigena Study Group. Effect on post-operative pulmonary complications frequency of high flow nasal oxygen versus standard oxygen therapy in patients undergoing esophagectomy for cancer: study protocol for a randomized controlled trial-OSSIGENA study. J Thorac Dis. 2024 Aug 31;16(8):5388-5398. doi: 10.21037/jtd-24-575. Epub 2024 Aug 13.

Reference Type DERIVED
PMID: 39268119 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OSSIGENA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.