NCT05718284

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 1, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

January 30, 2023

Last Update Submit

July 27, 2023

Conditions

Esophageal CancerPostoperative Pulmonary AtelectasisPostoperative PneumoniaPostoperative PneumothoraxPostoperative Infection of IncisionPostoperative Acute Myocardial Infarction

Keywords

esophageal canceranesthesiahigh flow nasal cannulapneumoniaesophagectomyacute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • CARDIO-VASCULAR COMPLICATIONS

    within 30 days after surgery

Study Arms (2)

HFNC

EXPERIMENTAL

Administration of high flow nasal oxygen after extubation for 48 hours

Device: AIRVO2

STANDARD OXYGEN

OTHER

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

Other: STANDARD CARE

Interventions

AIRVO2DEVICE

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

HFNC
STANDARD CAREOTHER

APPLICATION OF OXYGEN THROUGH STANDARD CARE FOR 48 HOURS AFTER ESOPHAGECTOMY

STANDARD OXYGEN

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective esophagectomy for cancer
  • METS≥4
  • AGE 18-85
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 33323061BACKGROUND

  • 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.

    PMID: 33548991BACKGROUND

  • 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.

    PMID: 39268119DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsPulmonary AtelectasisPneumonia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesLung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsInfections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

CRISTIAN DEANA, MD

CONTACT

+393333745660CRISTIAN.DEANA@ASUFC.SANITA.FVG.IT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MEDICAL doctor, Anesthesiologist and Critical Care Physician

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

April 1, 2023

Primary Completion

October 1, 2024

Study Completion

January 1, 2025

Last Updated

August 1, 2023

Record last verified: 2023-04

Locations

IT(1)