Pulmonary DiseaseNCT05362526
High Flow vs Conventional Oxygen in Head and Neck Surgery
A study testing High flow humidification and Conventional cool mist aerosol humidification in people with Pulmonary Disease, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- High flow humidification and Conventional cool mist aerosol humidification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read the detailed description
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
- Pulmonary Disease
- Being tested
- High flow humidification, Conventional cool mist aerosol humidification
- Keywords
- Head neck surgery, heated humidification, cool humidification
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%)
| Study group | Role | What they receive |
|---|---|---|
| High flow with tracheostomy interface | Experimental | Patient will be placed on heated humidified high flow after surgery. Receives: Device: High flow humidification |
| Conventional Oxygen Therapy | Active comparator | Pt will be placed on conventional oxygen therapy after surgery. Receives: Device: Conventional cool mist aerosol humidification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 14
Secondary outcomes (2)
Percentage of Patients Decannulated
Number of patients who were decannulated prior to discharge.
Measured: 35 days
Hospital Length of Stay
Number of days from admission to hospital discharge.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Rui Fernandes, MD, DMD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362526
- Sponsor's protocol ID
- IRB202102700
- Other IDs
- AGR00023048
- Status last verified
- Oct 2025
- First submitted
- 2 May 2022
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05362526
- Acronym / sponsor ID
- IRB202102700
- Conditions
- Pulmonary Disease
- Keywords
- Head neck surgery, heated humidification, cool humidification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Posted 3 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow with tracheostomy interface | Experimental | Device: High flow humidificationPatient will be placed on heated humidified high flow after surgery. |
| Conventional Oxygen Therapy | Active comparator | Device: Conventional cool mist aerosol humidificationPt will be placed on conventional oxygen therapy after surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow humidificationHigh 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 | High flow with tracheostomy interface |
| Conventional cool mist aerosol humidificationSubjects 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%) | Device | Conventional Oxygen Therapy |
Primary outcome
Proportion of Patients With Post-operative Pulmonary Complication
Time frame: Day 14
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
2 secondary outcomes
Percentage of Patients Decannulated
Time frame: 35 days
Hospital Length of Stay
Time frame: 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Fernandes, MD, DMD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow humidification and Conventional cool mist aerosol humidification in people with Pulmonary Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Post-operative Pulmonary Complication (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.