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High Flow vs Conventional Oxygen in Head and Neck Surgery

University of Florida logo

University of Florida

Status

Completed

Conditions

Pulmonary Disease
COPD

Treatments

Device: HFOT using AIRVO2
Device: COT

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05362526
AGR00023048 (Other Identifier)
IRB202102700

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Ashleigh Weyh, MD; Maribel Ciampitti

Data sourced from clinicaltrials.gov

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