Trial Outcomes & Findings for High Flow vs Conventional Oxygen in Head and Neck Surgery (NCT NCT05362526)

NCT ID: NCT05362526

Last Updated: 2025-11-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: Day 14
• Results posted on: 2025-11-03

Participant Flow

56 consented and randomized.

Participant milestones

Measure	High Flow With Tracheostomy Interface Patient will be placed on heated humidified high flow after surgery. 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 chronic obstructive pulmonary disease) and then the clinician can recommend \>88%)	Conventional Oxygen Therapy Pt will be placed on conventional oxygen therapy after surgery. 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%)
Overall Study STARTED	26	30
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	HFOT (High Flow With Tracheostomy Interface) n=24 Participants Patient will be placed on heated humidified high flow after surgery. 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 60-30L 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%)	COT (Conventional Oxygen Therapy) n=25 Participants Pt will be placed on conventional oxygen therapy after surgery. 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%)	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=24 Participants	0 Participants n=25 Participants	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=24 Participants	10 Participants n=25 Participants	29 Participants n=49 Participants
Age, Categorical >=65 years	5 Participants n=24 Participants	15 Participants n=25 Participants	20 Participants n=49 Participants
Age, Continuous	56.1 years STANDARD_DEVIATION 13.5 • n=24 Participants	66.8 years STANDARD_DEVIATION 9.2 • n=25 Participants	61.57 years STANDARD_DEVIATION 12.56 • n=49 Participants
Sex: Female, Male Female	11 Participants n=24 Participants	7 Participants n=25 Participants	18 Participants n=49 Participants
Sex: Female, Male Male	13 Participants n=24 Participants	18 Participants n=25 Participants	31 Participants n=49 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	24 participants n=24 Participants	25 participants n=25 Participants	49 participants n=49 Participants
Body mass index	26.7 kilograms per square meter STANDARD_DEVIATION 8.9 • n=24 Participants	26.2 kilograms per square meter STANDARD_DEVIATION 6.8 • n=25 Participants	26.469 kilograms per square meter STANDARD_DEVIATION 7.83 • n=49 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	HFOT (High Flow With Tracheostomy Interface) n=24 Participants Patient will be placed on heated humidified high flow after surgery. 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 60-30L 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%)	COT (Conventional Oxygen Therapy) n=25 Participants Pt will be placed on conventional oxygen therapy after surgery. 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%)
Proportion of Patients With Post-operative Pulmonary Complication	2 Participants	11 Participants

SECONDARY outcome

Timeframe: 35 days

Number of patients who were decannulated prior to discharge.

Outcome measures

Measure	HFOT (High Flow With Tracheostomy Interface) n=24 Participants Patient will be placed on heated humidified high flow after surgery. 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 60-30L 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%)	COT (Conventional Oxygen Therapy) n=25 Participants Pt will be placed on conventional oxygen therapy after surgery. 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%)
Percentage of Patients Decannulated	18 Participants	23 Participants

SECONDARY outcome

Timeframe: 35 days

Number of days from admission to hospital discharge.

Outcome measures

Measure	HFOT (High Flow With Tracheostomy Interface) n=24 Participants Patient will be placed on heated humidified high flow after surgery. 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 60-30L 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%)	COT (Conventional Oxygen Therapy) n=25 Participants Pt will be placed on conventional oxygen therapy after surgery. 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%)
Hospital Length of Stay	10.125 days Standard Deviation 6.2	10.88 days Standard Deviation 6.3

Adverse Events

HFOT (High Flow With Tracheostomy Interface)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

COT (Conventional Oxygen Therapy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	HFOT (High Flow With Tracheostomy Interface) n=24 participants at risk Patient will be placed on heated humidified high flow after surgery. 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 60-30L 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%)	COT (Conventional Oxygen Therapy) n=25 participants at risk Pt will be placed on conventional oxygen therapy after surgery. 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%)
Metabolism and nutrition disorders hyperglycemia	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up, up to 2 months after surgery.	0.00% 0/25 • From enrollment until end of follow-up, up to 2 months after surgery.

Other adverse events

Adverse event data not reported

Additional Information

Ashleigh Wehy, MD

University of Florida

Phone: 9042449440

Email: amweyh@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place