NCT05362526

High Flow vs Conventional Oxygen in Head and Neck Surgery

Prevention of Pulmonary Complications Using High Flow With Tracheostomy Interface vs Conventional Oxygen Therapy in Patients After Major Head and Neck Surgery: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	High flow humidification	High flow is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. The subjects in this group will receive HFOT at a flow rate of 60-30 liters per minute, maximum concentration of 40%, which will be titrated by bedside nurse to maintain an oxygen saturation of 92% or greater (unless there is a history of COPD and then the clinician can recommend \>88%)
DEVICE	Conventional cool mist aerosol humidification	Subjects will be placed on aerosolized trach mask with cool humidification, and titrated to keep oxygen saturation \>92% (unless there is a history of COPD and then the clinician can recommend \>88%)

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-06-30
• Completion: 2024-07-01
• First posted: 2022-05-05
• Last updated: 2025-11-03
• Results posted: 2025-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study