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High Flow vs Conventional Oxygen in Head and Neck Surgery

NCT05362526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-11-03

Study results available
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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

Interventions

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%)

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%)

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Rui Fernandes, MD, DMD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-06-30
Completion
2024-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05362526 on ClinicalTrials.gov