Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03828578 |
Other study ID # |
223048 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2017 |
Est. completion date |
October 1, 2018 |
Study information
Verified date |
August 2023 |
Source |
Cardiff and Vale University Health Board |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.