Back to resultsHigh Flow Nasal Cannula After Esophagectomy (OSSIGENA1V)
Primary Purpose
Esophageal Cancer, Postoperative Pulmonary Atelectasis, Postoperative Pneumonia
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
AIRVO2
STANDARD CARE
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, anesthesia, high flow nasal cannula, pneumonia, esophagectomy, acute myocardial infarction
Eligibility Criteria
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
Sites / Locations
- Azienda Sanitaria Universitaria Friuli CentraleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
HFNC
STANDARD OXYGEN
Arm Description
Administration of high flow nasal oxygen after extubation for 48 hours
Administration of oxygen through standard devices (nasal cannulae, venturi mask, none)
Outcomes
Primary Outcome Measures
POST-OPERATIVE PULMONARY COMPLICATIONS
Describe the frequency of PPC that include: pneumonia, pleural effusion, pneumothorax, atelectasis, ARDS, aspiration pneumonia, trachea-bronchial lesion, air leak
Secondary Outcome Measures
CARDIO-VASCULAR COMPLICATIONS
Describe the frequency of myocardial infarction, pulmonary edema, cardiac arrest, pulmonary embolism, deep venous thrombosis, stroke, pericardtis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05718284
Brief Title
High Flow Nasal Cannula After Esophagectomy
Acronym
OSSIGENA1V
Official Title
High Flow Nasal Cannula Oxygen Administration Versus Standard Care After Esophagectomy for Cancer: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristian Deana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare the effect of HFNC versus standard oxygen administration after elective esophagectomy for cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFNC
Arm Type
Experimental
Arm Description
Administration of high flow nasal oxygen after extubation for 48 hours
Arm Title
STANDARD OXYGEN
Arm Type
Other
Arm Description
Administration of oxygen through standard devices (nasal cannulae, venturi mask, none)
Intervention Type
Device
Intervention Name(s)
AIRVO2
Intervention Description
APPLICATION OF HIGH FLOW NASAL CANNULA OXYGEN FOR 48 HOURS AFTER ESOPHAGECTOMY
Intervention Type
Other
Intervention Name(s)
STANDARD CARE
Intervention Description
APPLICATION OF OXYGEN THROUGH STANDARD CARE FOR 48 HOURS AFTER ESOPHAGECTOMY
Primary Outcome Measure Information:
Title
POST-OPERATIVE PULMONARY COMPLICATIONS
Description
Describe the frequency of PPC that include: pneumonia, pleural effusion, pneumothorax, atelectasis, ARDS, aspiration pneumonia, trachea-bronchial lesion, air leak
Time Frame
within 30 days after surgery
Secondary Outcome Measure Information:
Title
CARDIO-VASCULAR COMPLICATIONS
Description
Describe the frequency of myocardial infarction, pulmonary edema, cardiac arrest, pulmonary embolism, deep venous thrombosis, stroke, pericardtis
Time Frame
within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CRISTIAN DEANA, MD
Phone
+393333745660
Email
CRISTIAN.DEANA@ASUFC.SANITA.FVG.IT
Facility Information:
Facility Name
Azienda Sanitaria Universitaria Friuli Centrale
City
Udine
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CRISTIAN DEANA, MD
Phone
+390432552410
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33323061
Citation
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.
Results Reference
background
PubMed Identifier
33548991
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.
Results Reference
background
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High Flow Nasal Cannula After Esophagectomy
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