High Flow vs Conventional Oxygen in Head and Neck Surgery

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05362526

Collaborator

Fisher and Paykel Healthcare (Industry)

174

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease COPD	Device: HFOT using AIRVO2 Device: COT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HFOT (High flow with tracheostomy interface) Patient will be placed on heated humidified high flow after surgery.	Device: HFOT using AIRVO2 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 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%)
Active Comparator: COT (Conventional Oxygen Therapy) Pt will be placed on conventional oxygen therapy after surgery.	Device: COT 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%)

Arm

Intervention/Treatment

Experimental: HFOT (High flow with tracheostomy interface)

Patient will be placed on heated humidified high flow after surgery.

Device: HFOT using AIRVO2

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 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%)

Active Comparator: COT (Conventional Oxygen Therapy)

Pt will be placed on conventional oxygen therapy after surgery.

Device: COT

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%)

Outcome Measures

Primary Outcome Measures

Incidence of 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Exclusion Criteria:

<18 years of age

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Florida
Fisher and Paykel Healthcare

Investigators

Principal Investigator: Rui Fernandes, MD, DMD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT05362526

Other Study ID Numbers:

IRB202102700
AGR00023048

First Posted:

May 5, 2022

Last Update Posted:

Aug 15, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Florida

Head neck surgery

heated humidification

cool humidification

Additional relevant MeSH terms:

Lung Diseases

Study Results

No Results Posted as of Aug 15, 2022