CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
High flow humidification +1 moredevice
Likely dose
High flow oxygen therapy at 60-30 liters per minute with maximum concentration of 40%, titrated by bedsideAI-extracted
Key inclusion· 3
  • Undergoing major head and neck surgery that includes neck dissection
  • Major head and neck surgery defined as mean length of stay of three or more days
  • Surgery requires elective tracheostomy for airway protection or laryngectomy tube (total laryngectomy)
Key exclusion· 1
  • Age less than 18 years

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05362526
NCT05362526N/ACompleted

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

University of Florida·interventional·Posted May 5, 2022·Updated Nov 3, 2025

In Brief

A clinical study evaluating High flow humidification and Conventional cool mist aerosol humidification for Pulmonary Disease. Completed, enrolled 56 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 5, 2022
Enrollment StartJul 1, 2022
Primary CompletionJun 30, 2024
Study CompletionJul 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.2 years ago

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%)