Pulmonary Disease
Conditions
Keywords
Head neck surgery, heated humidification, cool humidification
Brief 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).
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.
Interventions
DEVICEHigh 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 COPD and then the clinician can recommend \>88%)
DEVICEConventional 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%)
Sponsors
Fisher and Paykel Healthcare
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* \<18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Post-operative Pulmonary Complication | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Decannulated | 35 days | Number of patients who were decannulated prior to discharge. |
| Hospital Length of Stay | 35 days | Number of days from admission to hospital discharge. |
Countries
United States
Participant flow
Recruitment details
56 consented and randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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%) | 24 |
| 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%) | 25 |
| Total | 49 |
Baseline characteristics
| Characteristic | HFOT (High Flow With Tracheostomy Interface) | COT (Conventional Oxygen Therapy) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 15 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 10 Participants | 29 Participants |
| Age, Continuous | 56.1 years STANDARD_DEVIATION 13.5 | 66.8 years STANDARD_DEVIATION 9.2 | 61.57 years STANDARD_DEVIATION 12.56 |
| Body mass index | 26.7 kilograms per square meter STANDARD_DEVIATION 8.9 | 26.2 kilograms per square meter STANDARD_DEVIATION 6.8 | 26.469 kilograms per square meter STANDARD_DEVIATION 7.83 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 24 participants | 25 participants | 49 participants |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 13 Participants | 18 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 0 / 24 | 0 / 25 |
| serious Total, serious adverse events | 1 / 24 | 0 / 25 |
Outcome results
Primary
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
Time frame: Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HFOT (High Flow With Tracheostomy Interface) | Proportion of Patients With Post-operative Pulmonary Complication | 2 Participants |
| COT (Conventional Oxygen Therapy) | Proportion of Patients With Post-operative Pulmonary Complication | 11 Participants |
Secondary
Hospital Length of Stay
Number of days from admission to hospital discharge.
Time frame: 35 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFOT (High Flow With Tracheostomy Interface) | Hospital Length of Stay | 10.125 days | Standard Deviation 6.2 |
| COT (Conventional Oxygen Therapy) | Hospital Length of Stay | 10.88 days | Standard Deviation 6.3 |
Secondary
Percentage of Patients Decannulated
Number of patients who were decannulated prior to discharge.
Time frame: 35 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HFOT (High Flow With Tracheostomy Interface) | Percentage of Patients Decannulated | 18 Participants |
| COT (Conventional Oxygen Therapy) | Percentage of Patients Decannulated | 23 Participants |