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High Flow vs Conventional Oxygen in Head and Neck Surgery

Primary Purpose

Pulmonary Disease, COPD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HFOT using AIRVO2
COT
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Disease focused on measuring Head neck surgery, heated humidification, cool humidification

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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 or laryngectomy tube in the case of total laryngectomy

Exclusion Criteria:

  • <18 years of age

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HFOT (High flow with tracheostomy interface)

COT (Conventional Oxygen Therapy)

Arm Description

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

Pt will be placed on conventional oxygen therapy after surgery.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
May 2, 2022
Last Updated
October 13, 2022
Sponsor
University of Florida
Collaborators
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05362526
Brief Title
High Flow vs Conventional Oxygen in Head and Neck Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, COPD
Keywords
Head neck surgery, heated humidification, cool humidification

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFOT (High flow with tracheostomy interface)
Arm Type
Experimental
Arm Description
Patient will be placed on heated humidified high flow after surgery.
Arm Title
COT (Conventional Oxygen Therapy)
Arm Type
Active Comparator
Arm Description
Pt will be placed on conventional oxygen therapy after surgery.
Intervention Type
Device
Intervention Name(s)
HFOT using AIRVO2
Intervention Description
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%)
Intervention Type
Device
Intervention Name(s)
COT
Intervention Description
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%)
Primary Outcome Measure Information:
Title
Incidence of post-operative pulmonary complication
Description
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)
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maribel Ciampitti
Phone
904-244-4690
Email
maribel.ciampitti@jax.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ashleigh Weyh, MD
Email
Ashleigh.Weyh@jax.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Fernandes, MD, DMD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maribel Ciampitti, MS
Phone
904-244-4690
Email
maribel.ciampitti@jax.ufl.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Bowman, MA
Email
Jennifer.Bowman@jax.ufl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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High Flow vs Conventional Oxygen in Head and Neck Surgery

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