Clinical trial NCT05418517: Hospital Acquired Pneumonia in Temporary Tracheostomy
Official title: The Incidence of Hospital Acquired Pneumonia in Patients Who Undergo Temporary Tracheostomy With Oromaxillofacial Resection and Reconstruction for Head and Neck Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Tracheostomy Complication
Hospital-acquired Pneumonia
Surgery
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2022-06-14
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who have head and neck cancer and require oromaxillofacial resection and reconstruction with a free flap

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital acquired pneumonia
timeFrame: 7 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
References: