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Hospital Acquired Pneumonia in Temporary Tracheostomy

NCT05418517 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 193

Last updated 2022-06-14

No results posted yet for this study

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

Interventions

PROCEDURE

Tracheostomy

temporary tracheostomy insertion

PROCEDURE

Overnight intubation

Patient who had overnight intubation

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-08-31
Completion
2022-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05418517 on ClinicalTrials.gov