Head and Neck CancerHAPNCT05418517
Hospital Acquired Pneumonia in Temporary Tracheostomy
An observational study of Head and Neck Cancer and Tracheostomy Complication, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Medical condition or disease under investigation: Oromaxillofacial surgery in head and neck cancer Purpose of research: Retrospective data analysis identifying hospital acquired pneumonia in patients who undergo temporary tracheostomy with oromaxillofacial surgery and free flap reconstruction Primary objective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Tracheostomy Complication, Hospital-acquired Pneumonia
- What is being tested?
- Tracheostomy and Overnight intubation
- Type of treatment
- Surgery or procedure
- How many people
- 193 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2022to Oct 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patient who have head and neck cancer and require oromaxillofacial resection and reconstruction with a free flap
Subject inclusion criteria
- Patients who underwent maxillofacial resection with free flap reconstruction and tracheostomy from 1st January 2018 to 31st December 2018.
- Patients who underwent maxillofacial resection with free flap reconstruction and with endotracheal intubation from 1st January 2014 to 31st December 2014
- Patients over the age of 18
Subject exclusion criteria
- Patients who did not undergo maxillofacial resection with free flap reconstruction and tracheostomy from 1st January 2018 to 31st December 2018 - not relevant and will not answer the study question
- Patients who did not undergo maxillofacial resection with free flap reconstruction and with endotracheal intubation from 1st January 2014 to 31st December 2014 - not relevant and will not answer the study question
- Patients under the age of 18
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Rachel S Wijayarathna, Bsc, 02071887188 ext. 50793, rachel.wijayarathna@gstt.nhs.uk
Gareth Jones, PhD, 02071885111, gareth.jones@gstt.nhs.uk
About this study
Official title: The Incidence of Hospital Acquired Pneumonia in Patients Who Undergo Temporary Tracheostomy With Oromaxillofacial Resection and Reconstruction for Head and Neck Cancer.
Medical condition or disease under investigation:
Oromaxillofacial surgery in head and neck cancer
Read more
Purpose of research:
Retrospective data analysis identifying hospital acquired pneumonia in patients who undergo temporary tracheostomy with oromaxillofacial surgery and free flap reconstruction
Primary objective:
Undertake an adequately powered, robustly designed observational cohort study that describes the rates of hospital acquired pneumonia in patients who undergo a tracheostomy and those that undergo overnight intubation during oromaxillofacial surgery for HNC.
Secondary objective:
To investigate whether smoking history, respiratory history (COPD, asthma) or size of tumour are associated with an increased risk of developing hospital acquired pneumonia.
Number of Subjects/Patients: 193 Study Type: Observational cohort
Main Inclusion Criteria:
Patients who underwent oromaxillofacial resection with free flap reconstruction and tracheostomy from 1st January 2018 to 31st December 2018.
Patients who underwent oromaxillofacial resection with free flap reconstruction and with overnight intubation from 1st January 2014 to 31st December 2014
Statistical Methodology and Analysis:
A power calculation has been used to determine the sample size required for statistical analysis of data. Statistical significance for rates of HAP will be tested between the two groups.
Read the detailed description
Trial objectives and purpose
- To select patients according to a pre-defined set of inclusion and exclusion criteria
- Collect pre-determined quantitative data relevant to the study question using hospital medical records
- Describe patient demographic data and explore any relationship between these and the development of a HAP
- Asses rates of HAP using historical medical data and pre-defined criteria that identifies hospital acquired pneumonia
- Describe rates of HAP in patients who did not have a tracheostomy inserted for maxillofacial surgery with free flap reconstruction
- Describe rates of HAP in patients who did have a tracheostomy inserted for maxillofacial surgery with free flap reconstruction
Study Design In 2017, a new maxillofacial surgeon was appointed to Guy's \& St Thomas' NHS Foundation Trust who's preference was to insert a temporary tracheostomy for all patients undergoing oromaxillofacial surgery with free flap reconstruction. Prior to this there was a wide variation in case selection with the majority of patients undergoing overnight intubation. Since subsequent practice has now changed and all patients now undergo tracheostomy insertion within OMFS, a prospective design is not possible, therefore, a single site retrospective observational design will be adopted, allowing data from two cohorts of patients identified to be collected within a feasbile timeframe dictated by the module deadlines. Electronic and paper notes of patients from cohorts before and after the change in maxillofacial surgical practice (2014 and 2018) will be screened.
- Being tested
- Tracheostomy, Overnight intubation
- Medical subject headings
- Head and Neck Neoplasms, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheostomyProcedure or surgery
temporary tracheostomy insertion
Overnight intubationProcedure or surgery
Patient who had overnight intubation
| Study group | Role | What they receive |
|---|---|---|
| oromaxillofacial surgery | Patients who underwent oromaxillofacial surgery Receives: Procedure: Tracheostomy; Procedure: Overnight intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital acquired pneumonia
Development of hospital acquired pneumonia according to BMJ best practice 'hospital acquired pneumonia' (non covid-19) diagnosis criteria
Measured: 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
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.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 193 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Principal investigator, Rachel Wijayarathna, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418517
- Sponsor's protocol ID
- IRAS ID295395
- Acronym
- HAP
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Hospital Acquired Pneumonia in Patients Who Undergo Temporary Tracheostomy With Oromaxillofacial Resection and Reconstruction for Head and Neck Cancer.
- ClinicalTrials.gov ID
- NCT05418517
- Acronym / sponsor ID
- HAP / IRAS ID295395
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 193 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jun 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 14 Jun 2022 (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.
Medical condition or disease under investigation:
Oromaxillofacial surgery in head and neck cancer
Purpose of research:
Retrospective data analysis identifying hospital acquired pneumonia in patients who undergo temporary tracheostomy with oromaxillofacial surgery and free flap reconstruction
Primary objective:
Undertake an adequately powered, robustly designed observational cohort study that describes the rates of hospital acquired pneumonia in patients who undergo a tracheostomy and those that undergo overnight intubation during oromaxillofacial surgery for HNC.
Secondary objective:
To investigate whether smoking history, respiratory history (COPD, asthma) or size of tumour are associated with an increased risk of developing hospital acquired pneumonia.
Number of Subjects/Patients: 193 Study Type: Observational cohort
Main Inclusion Criteria:
Patients who underwent oromaxillofacial resection with free flap reconstruction and tracheostomy from 1st January 2018 to 31st December 2018.
Patients who underwent oromaxillofacial resection with free flap reconstruction and with overnight intubation from 1st January 2014 to 31st December 2014
Statistical Methodology and Analysis:
A power calculation has been used to determine the sample size required for statistical analysis of data. Statistical significance for rates of HAP will be tested between the two groups.
Detailed description
Trial objectives and purpose
- To select patients according to a pre-defined set of inclusion and exclusion criteria
- Collect pre-determined quantitative data relevant to the study question using hospital medical records
- Describe patient demographic data and explore any relationship between these and the development of a HAP
- Asses rates of HAP using historical medical data and pre-defined criteria that identifies hospital acquired pneumonia
- Describe rates of HAP in patients who did not have a tracheostomy inserted for maxillofacial surgery with free flap reconstruction
- Describe rates of HAP in patients who did have a tracheostomy inserted for maxillofacial surgery with free flap reconstruction
Study Design In 2017, a new maxillofacial surgeon was appointed to Guy's \& St Thomas' NHS Foundation Trust who's preference was to insert a temporary tracheostomy for all patients undergoing oromaxillofacial surgery with free flap reconstruction. Prior to this there was a wide variation in case selection with the majority of patients undergoing overnight intubation. Since subsequent practice has now changed and all patients now undergo tracheostomy insertion within OMFS, a prospective design is not possible, therefore, a single site retrospective observational design will be adopted, allowing data from two cohorts of patients identified to be collected within a feasbile timeframe dictated by the module deadlines. Electronic and paper notes of patients from cohorts before and after the change in maxillofacial surgical practice (2014 and 2018) will be screened.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oromaxillofacial surgery | – | Procedure: Tracheostomy, Procedure: Overnight intubationPatients who underwent oromaxillofacial surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient who have head and neck cancer and require oromaxillofacial resection and reconstruction with a free flap
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 |
|---|---|---|
| Tracheostomytemporary tracheostomy insertion | Procedure or surgery | oromaxillofacial surgery |
| Overnight intubationPatient who had overnight intubation | Procedure or surgery | oromaxillofacial surgery |
Primary outcome
Hospital acquired pneumonia
Time frame: 7 days post surgery
Development of hospital acquired pneumonia according to BMJ best practice 'hospital acquired pneumonia' (non covid-19) diagnosis criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No. No plan to share data
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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.
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Tracheostomy Complication, run by Guy's and St Thomas' NHS Foundation Trust 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?
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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital acquired pneumonia (time frame: 7 days post surgery). 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 14 Jun 2022.