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

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease
• Intervention / Treatment: Device: High flow humidification; Device: Conventional cool mist aerosol humidification

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High flow with tracheostomy interface; Patient will be placed on heated humidified high flow after surgery.	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%)
Active Comparator: Conventional Oxygen Therapy; Pt will be placed on conventional oxygen therapy after surgery.	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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With Post-operative Pulmonary Complication	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); Pneumonia Diagnosis is suggested by a history of cough, dyspnea, pleuritic pain, or acute functional or cognitive decline, with abnormal vital signs (e.g., fever, tachycardia) and lung examination findings. Diagnosis should be confirmed by chest radiography or ultrasonography." [15]; Chronic pulmonary obstructive disease exacerbation "An event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum and beyond normal day-to-day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD" [16]; Adult respiratory distress syndrome (Berlin definition); Need for mechanical ventilation; Need for non-invasive mechanical ventilation	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Decannulated	Number of patients who were decannulated prior to discharge.	35 days
Hospital Length of Stay	Number of days from admission to hospital discharge.	35 days

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Rui Fernandes, MD, DMD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Head neck surgery; heated humidification; cool humidification
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: IRB202102700; AGR00023048 (Other Identifier: UFIRST)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No