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| ID | Type | Description | Link |
|---|---|---|---|
| AGR00023048 | Other Identifier | UFIRST |
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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High flow with tracheostomy interface | Experimental | Patient will be placed on heated humidified high flow after surgery. |
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| Conventional Oxygen Therapy | Active Comparator | Pt will be placed on conventional oxygen therapy after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow humidification | Device | 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%) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Post-operative Pulmonary Complication | Postoperative pulmonary complication will be defined as:
| Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Decannulated | Number of patients who were decannulated prior to discharge. | 35 days |
| Hospital Length of Stay | Number of days from admission to hospital discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Fernandes, MD, DMD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Jacksonville | Florida | 32209 | United States |
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56 consented and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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%) |
| FG001 | 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%) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HFOT (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 60-30L 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%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Post-operative Pulmonary Complication | Postoperative pulmonary complication will be defined as:
| Posted | Count of Participants | Participants | Day 14 |
|
From enrollment until end of follow-up, up to 2 months after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HFOT (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 60-30L 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%) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment | Elevated blood glucose levels requiring initiation or escalation of medical therapy, including initiation of a regular insulin sliding scale for glycemic control. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashleigh Wehy, MD | University of Florida | 9042449440 | amweyh@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2022 | Sep 5, 2025 | Prot_SAP_004.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| Conventional cool mist aerosol humidification | Device | 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%) |
|
| 35 days |
| BG001 | COT (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%) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass index | Mean | Standard Deviation | kilograms per square meter |
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| HFOT (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 60-30L 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%) |
| OG001 | COT (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%) |
|
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| Secondary | Percentage of Patients Decannulated | Number of patients who were decannulated prior to discharge. | Posted | Count of Participants | Participants | 35 days |
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| Secondary | Hospital Length of Stay | Number of days from admission to hospital discharge. | Posted | Mean | Standard Deviation | days | 35 days |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| 0 |
| 24 |
| EG001 | COT (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%) | 0 | 25 | 0 | 25 | 0 | 25 |
|
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