Clinical trial · Observational
Hospital Acquired Pneumonia in Temporary Tracheostomy
The Incidence of Hospital Acquired Pneumonia in Patients Who Undergo Temporary Tracheostomy With Oromaxillofacial Resection and Reconstruction for Head and Neck Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Hospital-acquired Pneumonia | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
| Tracheostomy Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Overnight intubation | Procedure | — | UNRESOLVED |
| Tracheostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- oromaxillofacial surgery
- description
- Patients who underwent oromaxillofacial surgery
- interventionNames
- Procedure: Tracheostomy
- Procedure: Overnight intubation
Primary outcomes (1)
- measure
- Hospital acquired pneumonia
- timeFrame
- 7 days post surgery
- description
- Development of hospital acquired pneumonia according to BMJ best practice 'hospital acquired pneumonia' (non covid-19) diagnosis criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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