High Flow vs Conventional Oxygen in Head and Neck Surgery

University of Florida56 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pulmonary Disease

Interventions

High flow humidificationDEVICE

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 humidificationDEVICE

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%)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: Day 14

Secondary Outcomes

Percentage of Patients Decannulated

Number of patients who were decannulated prior to discharge.

Time frame: 35 days

Hospital Length of Stay

Number of days from admission to hospital discharge.

Time frame: 35 days

Data from ClinicalTrials.gov

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