High Flow vs Conventional Oxygen in Head and Neck Surgery

Not Applicable

Completed

• Conditions: Pulmonary Disease; COPD
• Interventions: Device: HFOT using AIRVO2; Device: COT

• Registration Number: NCT05362526
• Lead Sponsor: University of Florida

Brief Summary

Patients undergoing major head and neck surgery are at risk for postoperative pulmonary complications. The goal of this randomized clinical trial is to evaluate the effectiveness of high flow heated humidified oxygen at preventing postoperative pulmonary complications after major head and neck surgery, when compared to conventional oxygen therapy (aerosol cool mist).

Detailed Description

Participants enrolled in this study are randomly assigned to receive either conventional oxygen therapy (aerosol cool mist) or heated humidified high flow oxygen via the trach after head and neck surgery. The study team then collects information regarding clinical outcomes to explore if there are differences between the two groups.

Study Timeline

• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Study Start: 2022-07-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients undergoing major head and neck surgery that includes any neck dissection
• Major head and neck surgery is defined as having a mean length of stay of three or more days, based on the diagnosis [14]
• Surgery requires an elective tracheostomy for airway protection or laryngectomy tube in the case of total laryngectomy

Exclusion Criteria

• <18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFOT (High flow with tracheostomy interface)	HFOT using AIRVO2	Patient will be placed on heated humidified high flow after surgery.
COT (Conventional Oxygen Therapy)	COT	Pt will be placed on conventional oxygen therapy after surgery.

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative pulmonary complication	Day 14	Postoperative pulmonary complication will be defined as atelectasis or infiltrate diagnosed by radiologist on any postoperative chest radiograph within first 14 days or discharge (whichever occurs first)

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States