Comparison of AIRVO High Flow Oxygen Therapy With Standard Care for Prevention of PPCs After Major H&N Surgery

NCT03828578 | Completed

• 1 other identifier: 223048
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing major head and neck surgery often develop breathing difficulties as a result of build up of sputum and difficulty taking deep breaths. Often as part of the surgery patients may also require a tracheotomy tube (a temporary tube placed into their airway) which is removed around 5-7 days after the operation. The presence of this tracheostomy tube increases the patient's risk of developing breathing problems, especially difficulty clearing sputum and reduced lung volumes. To reduce the risk of developing these problems, different forms of oxygen therapy and humidification are used. This normally involves using oxygen masks, nebulisers and other medications to help loosen the sputum and maintain blood oxygen levels. Another method of giving oxygen and humidification is through the use of AIRVO, which delivers the air / oxygen to the patient at higher rates as well as warming and humidifying the air. The aim of this study is to compare the AIRVO system to standard care in a small sample of patients (20 patients) undergoing major head and neck surgery involving insertion of a tracheostomy tube. The study will compare rates of breathing complications (e.g. pneumonia, reduced lung volume) as well as comparing the time to remove the tracheostomy tube and the time the patient is required to stay in hospital. These results will then be used to develop a larger funded study.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of participants diagnosed with post-operative Pulmonary Complications

  Up to 48hours post tracheostomy decannulation

Secondary Outcomes (4)

• Time to decannulation

  Up to 4 weeks

• Hospital length of stay

  Up to 4 weeks

• Amount of physiotherapy intervention recieved by each participant

  Up to 4 weeks

• Feasability of recruitment, randomisation, delivery of intervention, and completion of outcome measures

  Up to 4 weeks

Study Arms (2)

High flow oxygen therapy

EXPERIMENTAL

Patients allocated to the intervention group will receive high flow oxygen therapy via the tracheostomy tube from cessation of mechanical ventilation. The HFOT will provide oxygen therapy at a flow rate of 50-60 litres per minute at a FiO2 titrated by the bedside clinician to maintain a peripheral oxygen saturation of 95% of more (unless otherwise clinically indicated and documented by an appropriate consultant). Once transferred to the ward patients will continue to receive HFOT 24 hours per day at a rate of 50-60 litres per minute at a maximum oxygen concentration of 40% to achieve oxygen saturations 95% and above (unless otherwise documented). Patients may be disconnected from the HFOT for short periods for toileting, mobilising etc. Tracheostomy weaning will continue as per standard practice with an aim of cuff deflation followed by decannulation once clinically appropriate. systems. Following decannulation patients will resort to standard oxygen therapy as needed.

Procedure: High flow oxygen therapy

Standard Care

NO INTERVENTION

Patients randomised to the standard care study arm will receive routine post-operative care as currently performed within the host organisation. Following cessation of mechanical ventilation, oxygen therapy will be delivered using equipment and rates appropriate to the clinical picture. On transfer to the ward patients will continue with existing methods of oxygen therapy and will be weaned from these accordingly. Patients will continue to use heat moisture exchanges (e.g. Swedish nose or Buchannan protectors) as clinically indicated, as well as having saline nebulisers prescribed and administered as per standard. Tracheostomy weaning will continue in accordance with current practice. Data on all of the applied procedures will be recorded.

Interventions

High flow oxygen therapy PROCEDURE

High flow oxygen therapy delivered via Airvo2

High flow oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing head and neck surgery with microvascular reconstruction and involving insertion of a tracheostomy

You may not qualify if:

• Under 18 years old
• Lack of consent
• Consultant request

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Cardiff and Vale University Health Board

Cardiff, CF144XW, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: February 4, 2019
• Study Start: April 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)