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Completed

NCT Number: NCT05362526

High Flow vs Conventional Oxygen in Head and Neck Surgery

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).

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Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Jacksonville, Florida, 32209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%)

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%)

Primary outcomes

  1. Proportion of Patients With Post-operative Pulmonary Complication

    Time frame: 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)
    • 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

Secondary outcomes

  1. Percentage of Patients Decannulated

    Time frame: 35 days

    Number of patients who were decannulated prior to discharge.

  2. Hospital Length of Stay

    Time frame: 35 days

    Number of days from admission to hospital discharge.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 5, 2022
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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