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High Flow vs Conventional Oxygen for Lung Disease

N/A
Recruiting
Led By Rui Fernandes, MD, DMD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14
Awards & highlights

Study Summary

This trialtests if heated, humidified oxygen helps prevent breathing problems after major head and neck surgery.

Who is the study for?
This trial is for adults undergoing major head and neck surgery that requires a tracheostomy or laryngectomy tube, with an expected hospital stay of three days or more. It's not suitable for those under 18.Check my eligibility
What is being tested?
The study compares two oxygen delivery methods after head and neck surgery: high flow heated humidified oxygen (HFOT) using AIRVO2 versus conventional cool mist oxygen therapy (COT).See study design
What are the potential side effects?
Potential side effects may include dryness or irritation in the nose and throat, discomfort from the equipment, breathing difficulties, and possible skin breakdown around the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had major surgery on my head or neck that required a hospital stay of 3 or more days.
Select...
I need a tracheostomy or laryngectomy tube for my upcoming surgery.
Select...
I am having major surgery on my head or neck that includes removing lymph nodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of post-operative pulmonary complication

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HFOT (High flow with tracheostomy interface)Experimental Treatment1 Intervention
Patient will be placed on heated humidified high flow after surgery.
Group II: COT (Conventional Oxygen Therapy)Active Control1 Intervention
Pt will be placed on conventional oxygen therapy after surgery.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,333 Previous Clinical Trials
714,377 Total Patients Enrolled
Fisher and Paykel HealthcareIndustry Sponsor
119 Previous Clinical Trials
9,674 Total Patients Enrolled
Rui Fernandes, MD, DMDPrincipal InvestigatorUniversity of Florida
3 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

COT Clinical Trial Eligibility Overview. Trial Name: NCT05362526 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: HFOT (High flow with tracheostomy interface), COT (Conventional Oxygen Therapy)
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: COT Highlights & Side Effects. Trial Name: NCT05362526 — N/A
COT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05362526 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals below the age of fifty eligible for this trial?

"This medical trial is only open to candidates aged between 18 and 100. For younger individuals, there are 37 clinical trials available while those over 65 have access to 472 options."

Answered by AI

What requirements must potential participants meet to join this clinical investigation?

"This clinical study is enrolling 214 participants with chronic airflow obstruction from ages 18 to 100. Applicants must meet specific criteria, including undergoing major head and neck surgery (defined as a mean length of stay greater than three days) and requiring an elective tracheostomy for airway protection or laryngectomy tube in the case of total laryngectomy."

Answered by AI

Is there capacity for more participants in this experiment?

"Affirmative. According to the research found on clinicaltrials.gov, this investigation is actively seeking participants. The experiment was first introduced on July 1st 2022 and its information was most recently modified on October 13th 2022. 214 people are required from a single medical centre for successful completion of this trial."

Answered by AI

What is the current enrollment of participants in this investigation?

"Affirmative. Clinicaltrials.gov records confirm that this medical study, which first appeared on July 1st 2022, is actively recruiting 214 patients from a single site for participation."

Answered by AI
~80 spots leftby Mar 2025