Hospital Acquired Pneumonia in Temporary Tracheostomy
United Kingdom193 participantsStarted 2022-06
Plain-language 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:
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.