Contact information
Type
Scientific
Primary contact
Prof Markus Weigand
ORCID ID
Contact details
Rudolf-Buchheim-Street 7
Giessen
35392
Germany
Markus.Weigand@chiru.med.uni-giessen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A prospective randomised trial to compare the effects early versus late Percutaneous Dilatational Tracheostomy (PTD) after incubation on the rate of Ventilator-Associated Pneumonia (VAP), mortality and other factors in critically ill patients on long-term ventilation.
Acronym
Study hypothesis
Long-term ventilation in intensive care units is associated with several problems such as increased mortality, increased rates of ventilator associated pneumonia (VAP), prolonged time of hospitalisation, and thus, leads to enormous financial consequences. While the influence of tracheostomy on VAP incidence, duration of ventilation, and time of hospitalisation has already been analyzed in several studies, the point of timing of the tracheostomy procedure on patient's mortality is still controversial. Within 2 years, 100 critically ill, mainly surgical patients entered this prospective randomized study. A percutaneous dilatational tracheostomy (PDT) was performed either early (4 days after intubation, 2.8 days median) or late (more than 6 days after intubation, 8.1 days median) after intubation. We compared both groups concerning outcome, VAP incidence and duration of hospitalisation and ventilation. This was a cross-departmental trial with collaboration between the Dept. of Anaethesiology, Dept. of Surgery Dept. of Neurosurgery and Dept. of Neurology.
Hypotheses:
1. Early tracheostomy is associated with a decreased mortality in critically ill surgical patients.
2. Early PDT performance, in comparison with late tracheostomy, is associated with decreased rates of VAP, duration of ventilation and time of hospitalization both in hospital and in (Intensive Care Units (ICUs).
Ethics approval
Ethics approval was received by the Ethics board of the University Hospital of Giessen, Germany in January 2005.
Study design
Single centre cross-departmental prospective randomised active controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
Intensive Care Units (ICUs); Percutaneous Dilatational Tracheostomy (PTD); ventilatory support
Intervention
After intubation patients either entered the early (ET) or the late tracheostomy (LT) trunk of this study:
In ET patients a percutaneous dilatational tracheostomy was performed within 4 days after intubation/trauma/surgery in LT patients the same procedure was performed after more than 6 days of intubation.
The Acute Physiology And Chronic Health Evaluation II (APACHE II) score was used to define the severity of the trauma. In each group 25 patients with APACHE II < 25 and > 25 were recruited.
Patients were followed until discharged from the hospital or rehabilitation centre.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
1. VAP as defined by
1.1. Clinical Pulmonary Infection Score (CPIS)
1.2. Sequential Organ Failure Assessment (SOFA) score
2. APACHE II score
3. Simplified acute physiology score (SAPS)
4. Temperature
5. Laboratory values
5.1. C-Reactive Protein (CRP)
5.2. Leukocytes
6. Thoracic X-ray
7. Days in ICU/hospital
8. Hours of ventilatory support
APACHE II score was measured at baseline, all other outcomes were measured daily.
Secondary outcome measures
None
Overall trial start date
02/01/2005
Overall trial end date
02/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Critically-ill patients requiring ventilatory support and intubation, recruited from the following three ICUs: surgical, neurological, neurosurgical.
2. Expected time of ventilation > 21 days
3. Age > 18 years
4. Informed consent that the patient may be included into the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Anatomic variants or deformities of the larynx, trachea, and collum
2. Pre-existing tracheostomy
3. Pre-existing pneumonia
4. Critical trauma of the cervical vertebral column
5. Coagulopathy (thrombocytes < 60,000 per μl, prothrombin time > 40 seconds, international normalized ratio > 1.4)
6. Estimated to die within the next 24 h
7. Planned permanent tracheostomy (after laryngectomy)
8. More than 3 days of ventilation before entry into the study
Recruitment start date
02/01/2005
Recruitment end date
02/01/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Rudolf-Buchheim-Street 7
Giessen
35392
Germany
Sponsor information
Organisation
University Hospital of Giessen (Germany)
Sponsor details
Department of Anaesthesiology and Intensive Care Medicine
Rudolf-Buchheim-Street 7
Giessen
35392
Germany
Andreas.Hecker@chiru.med.uni-giessen.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital of Giessen (Germany) - Department of Anaesthesiology and Intensive Care Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary