Esophageal CancerOSSIGENA1VNCT05718284
High Flow Nasal Cannula After Esophagectomy
A study testing AIRVO2 in people with Esophageal Cancer and Postoperative Pulmonary Atelectasis, run by Cristian Deana at 1 site in Italy.
Trial summary
This study will compare the effect of HFNC versus standard oxygen administration after elective esophagectomy for cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Cancer, Postoperative Pulmonary Atelectasis, Postoperative Pneumonia
- What is being tested?
- AIRVO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective esophagectomy for cancer
- METS≥4
- AGE 18-85
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100
CRISTIAN DEANA, MD, +390432552410
About this study
Official title: 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.
- Conditions
- Esophageal Cancer, Postoperative Pulmonary Atelectasis, Postoperative Pneumonia, Postoperative Pneumothorax, Postoperative Infection of Incision, Postoperative Acute Myocardial Infarction
- Being tested
- AIRVO2, STANDARD CARE
- Keywords
- esophageal cancer, anesthesia, high flow nasal cannula, pneumonia, esophagectomy, acute myocardial infarction
- Medical subject headings
- Esophageal Neoplasms, Pulmonary Atelectasis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIRVO2Device
APPLICATION OF HIGH FLOW NASAL CANNULA OXYGEN FOR 48 HOURS AFTER ESOPHAGECTOMY
STANDARD CAREOther
APPLICATION OF OXYGEN THROUGH STANDARD CARE FOR 48 HOURS AFTER ESOPHAGECTOMY
| Study group | Role | What they receive |
|---|---|---|
| HFNC | Experimental | Administration of high flow nasal oxygen after extubation for 48 hours Receives: Device: AIRVO2 |
| STANDARD OXYGEN | Other | Administration of oxygen through standard devices (nasal cannulae, venturi mask, none) Receives: Other: STANDARD CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
POST-OPERATIVE PULMONARY COMPLICATIONS
Describe the frequency of PPC that include: pneumonia, pleural effusion, pneumothorax, atelectasis, ARDS, aspiration pneumonia, trachea-bronchial lesion, air leak
Measured: within 30 days after surgery
Secondary outcomes (1)
CARDIO-VASCULAR COMPLICATIONS
Describe the frequency of myocardial infarction, pulmonary edema, cardiac arrest, pulmonary embolism, deep venous thrombosis, stroke, pericardtis
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Apr 2023
- Primary completionOct 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristian Deana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cristian Deana, Azienda Sanitaria-Universitaria Integrata di Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718284
- Sponsor's protocol ID
- OSSIGENA
- Acronym
- OSSIGENA1V
- Status last verified
- Apr 2023
- First submitted
- 30 Jan 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33323061Xia 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.
PubMed 33548991Deana 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.
PubMed 39268119
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Oxygen Administration Versus Standard Care After Esophagectomy for Cancer: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05718284
- Acronym / sponsor ID
- OSSIGENA1V / OSSIGENA
- Conditions
- Esophageal Cancer, Postoperative Pulmonary Atelectasis, Postoperative Pneumonia, Postoperative Pneumothorax, Postoperative Infection of Incision, Postoperative Acute Myocardial Infarction
- Keywords
- esophageal cancer, anesthesia, high flow nasal cannula, pneumonia, esophagectomy, acute myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Cristian DeanaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effect of HFNC versus standard oxygen administration after elective esophagectomy for cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC | Experimental | Device: AIRVO2Administration of high flow nasal oxygen after extubation for 48 hours |
| STANDARD OXYGEN | Other | Other: STANDARD CAREAdministration of oxygen through standard devices (nasal cannulae, venturi mask, none) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective esophagectomy for cancer
- METS≥4
- AGE 18-85
- Written informed consent
Key exclusion criteria (7 listed)
- ASA>3
- COPD≥ III stage according to GOLD criteria
- FEV1<50%
- EF<30%
- NYHA>2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIRVO2APPLICATION OF HIGH FLOW NASAL CANNULA OXYGEN FOR 48 HOURS AFTER ESOPHAGECTOMY | Device | HFNC |
| STANDARD CAREAPPLICATION OF OXYGEN THROUGH STANDARD CARE FOR 48 HOURS AFTER ESOPHAGECTOMY | Other | STANDARD OXYGEN |
Primary outcome
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
1 secondary outcome
CARDIO-VASCULAR COMPLICATIONS
Time frame: within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 33323061Deana 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.
- Background: PubMed 33548991Xia 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.
- Derived from this study: PubMed 39268119Deana 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.
- Individual participant dataSharing planned: Undecided
Related trials for Esophageal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIRVO2 in people with Esophageal Cancer and Postoperative Pulmonary Atelectasis, run by Cristian Deana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CRISTIAN DEANA, MD (+393333745660, CRISTIAN.DEANA@ASUFC.SANITA.FVG.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POST-OPERATIVE PULMONARY COMPLICATIONS (time frame: within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05718284, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.