High Flow vs Conventional Oxygen in Head and Neck Surgery

Study Overview
=================
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).

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

Conditions
-----------------
Pulmonary Disease, COPD

Intervention / Treatment
-----------------
* Device: HFOT using AIRVO2
* Device: COT


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFOT (High flow with tracheostomy interface)<br>Patient will be placed on heated humidified high flow after surgery. | Device: HFOT using AIRVO2<br>* The AIRVO 2 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%)<br>|
| Active Comparator: COT (Conventional Oxygen Therapy)<br>Pt will be placed on conventional oxygen therapy after surgery. | Device: COT<br>* 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%)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of 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) | Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head neck surgery, heated humidification, cool humidification