Hospital Acquired Pneumonia in Temporary Tracheostomy

NCT05418517 | Unknown

• 1 other identifier: IRAS ID295395
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Tracheostomy Complication; Hospital-acquired Pneumonia; Surgery

Outcome Measures

Primary Outcomes (1)

• Hospital acquired pneumonia

  Development of hospital acquired pneumonia according to BMJ best practice 'hospital acquired pneumonia' (non covid-19) diagnosis criteria

  7 days post surgery

Study Arms (1)

oromaxillofacial surgery

Patients who underwent oromaxillofacial surgery

Procedure: Tracheostomy; Procedure: Overnight intubation

Interventions

Tracheostomy PROCEDURE

temporary tracheostomy insertion

oromaxillofacial surgery

Overnight intubation PROCEDURE

Patient who had overnight intubation

oromaxillofacial surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who have head and neck cancer and require oromaxillofacial resection and reconstruction with a free flap

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Healthcare-Associated Pneumonia

Interventions

Tracheostomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Ostomy; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Highly specialist physiotherapist - head & neck oncology

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 14, 2022
• Study Start: June 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)