High Flow vs Conventional Oxygen in Head and Neck Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-07-01

Brief Summary

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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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Detailed Description

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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

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Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High flow with tracheostomy interface

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

Group Type EXPERIMENTAL

High flow humidification

Intervention Type 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 Oxygen Therapy

Pt will be placed on conventional oxygen therapy after surgery.

Group Type ACTIVE_COMPARATOR

Conventional cool mist aerosol humidification

Intervention Type 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%)

Interventions

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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%)

Intervention Type 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%)

Intervention Type DEVICE

Eligibility Criteria

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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