Hospital Acquired Pneumonia in Temporary Tracheostomy

• Conditions: Surgery; Tracheostomy Complication; Head and Neck Cancer; Hospital-acquired Pneumonia
• Interventions: Procedure: Tracheostomy; Procedure: Overnight intubation

• Registration Number: NCT05418517
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Last Update Submitted: 2022-06-10
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Primary Completion: 2022-08
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
oromaxillofacial surgery	Tracheostomy	Patients who underwent oromaxillofacial surgery
oromaxillofacial surgery	Overnight intubation	Patients who underwent oromaxillofacial surgery

Primary Outcome Measures

Name	Time	Method
Hospital acquired pneumonia	7 days post surgery	Development of hospital acquired pneumonia according to BMJ best practice 'hospital acquired pneumonia' (non covid-19) diagnosis criteria

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom