High Flow Nasal Cannula After Esophagectomy (OSSIGENA1V)

Cristian Deana

Status: Enrolling

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

Treatments: Device: AIRVO2; Other: STANDARD CARE

Study type: Interventional

Funder types: Other

Identifiers

NCT05718284

OSSIGENA

Details and patient eligibility

About

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

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

HFNC

Experimental group

Description:

Administration of high flow nasal oxygen after extubation for 48 hours

Treatment:

Device: AIRVO2

STANDARD OXYGEN

Other group

Description:

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

Treatment:

Other: STANDARD CARE