Clinical trial NCT03828578: Comparison of AIRVO High Flow Oxygen Therapy With Standard Care for Prevention of PPCs After Major H&N Surgery
Official title: Comparison of AIRVO High Flow Oxygen Therapy With Standard Care for Prevention of Post-operative Pulmonary Complications After Major Head and Neck Surgery Involving Insertion of a Tracheostomy - A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
First posted: 2019-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Detailed description: Major head and neck surgery involving micro-vascular reconstructions are prolonged procedures with considerable post operative risk. Not only do patients have prolonged time in theatre, the surgery involves two distinct surgical sites (head \& neck site and peripheral flap donor site), and requires the patient to be admitted to a high care area for overnight sedation and ventilation. This combined with the presence of significant co-morbidities such as hypertension, cardiomyopathy and respiratory disease, place the patient at significant risk of post-operative complications. A recent prospective cohort study reported complication rates in nearly 65% of cases, of which 29% were of pulmonary origin. Furthermore, of these, 14 patients required treatment in the intensive care or high dependency. Interestingly, and in contrast to other research3, neither pre-operative smoking nor the presence of pre-existing lung disease predicted pulmonary complications.

The risks of post-operative pulmonary complications (PPCs) seem to be further increased in those patients requiring a tracheostomy. This tracheostomy is required to facilitate access to the tumour location and to provide post-operative airway protection in the presence of significant swelling or oedema. The risks of tracheostomy are well known4. Patients are prone to increased rates of infection, poor sputum clearance and inadequate humidification. These complications lead to prolonged admissions, delays in tracheostomy weaning and considerable healthcare related costs. To overcome these issues national guidance documents have identified the need to provide adequate humidification to prevent mucus plugging, as well as the provision of increased nursing care for stoma site cleaning and inner tube care. Historically, humidification has been provided by heated systems however due to perceived increased infection risk this has fallen out of favour and now passive humidification systems such as heat moisture exchangers have become more popular.

Clearly, the combination of the risks of major head and neck surgery and those of a tracheostomy, place the patient at significant risk. As such it is essential to develop new post-operative management protocols to reduce the occurrence of post-operative complications.

AIRVOTM (a form of non-invasive high flow oxygen therapy, HFOT), which delivers high flow heated and humidified oxygen and air via a tracheostomy tube at a prescribed fraction of inspired oxygen and a maximum flow of 60 L/min, is an attractive alternative to conventional oxygen therapy. Previous studies have shown that HFOT therapy generates a flow-dependent positive airway pressure and improves oxygenation by increasing end-expiratory lung volume, thus suggesting a possible alveolar recruitment associated with high-flow therapy. Although widely used in other clinical areas including patients with tracheostomy tubes, HFOT delivered in the AIRVOTM system has yet to be evaluated in the Head and Neck surgery population.

This study aims to compare the effects of application of HFOT(delivered via AIRVOTM) therapy and conventional oxygen and humidification administration after major head and neck surgery involving insertion of a tracheostomy tube on postoperative pulmonary complications. The study will also compare post-operative length of stay, time to tracheostomy tube cuff deflation, tracheostomy tube decannulation, antibiotic use and post-operative physiotherapy requirements.

The results of this proof of concept study will be used to further develop local protocols and to inform a grant funded multi-centre trial.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of participants diagnosed with post-operative Pulmonary Complications
timeFrame: Up to 48hours post tracheostomy decannulation
Secondary outcomes:
measure: Time to decannulation
timeFrame: Up to 4 weeks
measure: Hospital length of stay
timeFrame: Up to 4 weeks
measure: Amount of physiotherapy intervention recieved by each participant
timeFrame: Up to 4 weeks
measure: Feasability of recruitment, randomisation, delivery of intervention, and completion of outcome measures
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board
Study officials:
References: