Condition category
Surgery
Date applied
23/01/2010
Date assigned
19/02/2010
Last edited
19/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes