High Flow vs Conventional Oxygen in Head and Neck Surgery

NCT05362526 | Completed Results FDA Device

• 2 other identifiers: IRB202102700AGR00023048
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Disease

Keywords

Head neck surgery; heated humidification; cool humidification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Patients Decannulated

  35 days

• Hospital Length of Stay

  35 days

Study Arms (2)

High flow with tracheostomy interface

EXPERIMENTAL

Patient will be placed on heated humidified high flow after surgery.

Device: High flow humidification

Conventional Oxygen Therapy

ACTIVE COMPARATOR

Pt will be placed on conventional oxygen therapy after surgery.

Device: Conventional cool mist aerosol humidification

Interventions

High flow humidification DEVICE

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%)

High flow with tracheostomy interface

Conventional cool mist aerosol humidification DEVICE

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%)

Conventional Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<18 years of age

Sponsors & Collaborators

• University of Florida: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

• Title: Ashleigh Wehy, MD
• Organization: University of Florida

amweyh@gmail.com

9042449440

Study Officials

• Rui Fernandes, MD, DMD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: July 1, 2024
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)