N/A
N=56
High Flow vs Conventional Oxygen in Head and Neck Surgery
Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT05362526 ↗Enrolled (actual)
56
Serious AEs
2.0%
Results posted
Nov 2025
Primary outcome: Primary: Proportion of Patients With Post-operative Pulmonary Complication — 2; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High flow humidification (Device); Conventional cool mist aerosol humidification (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Post-operative Pulmonary Complication |
2; 11 | — |
| SECONDARY Percentage of Patients Decannulated |
18; 23 | — |
| SECONDARY Hospital Length of Stay |
10.125; 10.88 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05362526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.