High Flow Nasal Cannula After Esophagectomy

Not Applicable

Recruiting

• Conditions: Postoperative Acute Myocardial Infarction; Postoperative Pneumonia; Postoperative Pneumothorax; Postoperative Infection of Incision; Postoperative Pulmonary Atelectasis; Esophageal Cancer
• Interventions: Device: AIRVO2; Other: STANDARD CARE

• Registration Number: NCT05718284
• Lead Sponsor: Cristian Deana

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-08
• Status Verified: 2023-04
• Study Start: 2023-04-01
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-10
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFNC	AIRVO2	Administration of high flow nasal oxygen after extubation for 48 hours
STANDARD OXYGEN	STANDARD CARE	Administration of oxygen through standard devices (nasal cannulae, venturi mask, none)

Primary Outcome Measures

Name	Time	Method
POST-OPERATIVE PULMONARY COMPLICATIONS	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

Secondary Outcome Measures

Name	Time	Method
CARDIO-VASCULAR COMPLICATIONS	within 30 days after surgery	Describe the frequency of myocardial infarction, pulmonary edema, cardiac arrest, pulmonary embolism, deep venous thrombosis, stroke, pericardtis

Trial Locations

Locations (1)

Azienda Sanitaria Universitaria Friuli Centrale; 🇮🇹 Udine, Italy