Head and Neck CancerNCT03828578
Comparison of AIRVO High Flow Oxygen Therapy With Standard Care for Prevention of PPCs After Major H&N Surgery
A study testing High flow oxygen therapy in people with Head and Neck Cancer, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- High flow oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2017to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing head and neck surgery with microvascular reconstruction and involving insertion of a tracheostomy
Who cannot join
- Under 18 years old
- Lack of consent
- Consultant request
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiff and Vale University Health Board
Cardiff, CF144XW
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- High flow oxygen therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow oxygen therapyProcedure or surgery
High flow oxygen therapy delivered via Airvo2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants diagnosed with post-operative Pulmonary Complications
Measured: Up to 48hours post tracheostomy decannulation
Secondary outcomes (4)
Time to decannulation
Measured in days
Measured: Up to 4 weeks
Hospital length of stay
Measured in days
Measured: Up to 4 weeks
Amount of physiotherapy intervention recieved by each participant
Measured in minutes
Measured: Up to 4 weeks
Feasability of recruitment, randomisation, delivery of intervention, and completion of outcome measures
Measured in percentages
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Apr 2017
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Paul Twose, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828578
- Sponsor's protocol ID
- 223048
- Status last verified
- Aug 2023
- First submitted
- 19 Jan 2019
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03828578
- Acronym / sponsor ID
- 223048
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow oxygen therapy | Experimental | Procedure: High flow oxygen therapyPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing head and neck surgery with microvascular reconstruction and involving insertion of a tracheostomy
Key exclusion criteria (3 listed)
- Under 18 years old
- Lack of consent
- Consultant request
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow oxygen therapyHigh flow oxygen therapy delivered via Airvo2 | Procedure or surgery | High flow oxygen therapy |
Primary outcome
Percentage of participants diagnosed with post-operative Pulmonary Complications
Time frame: Up to 48hours post tracheostomy decannulation
4 secondary outcomes
Time to decannulation
Time frame: Up to 4 weeks
Hospital length of stay
Time frame: Up to 4 weeks
Amount of physiotherapy intervention recieved by each participant
Time frame: Up to 4 weeks
Feasability of recruitment, randomisation, delivery of intervention, and completion of outcome measures
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow oxygen therapy in people with Head and Neck Cancer, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants diagnosed with post-operative Pulmonary Complications (time frame: Up to 48hours post tracheostomy decannulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.