Clinical Trials Logo
  1. Home
  2. Respiratory Insufficiency
  3. NCT02284438
  4. Details
NCT02284438 Clinical Trial

Biofilm Formation on Different Endotracheal Tube Materials

Respiratory Insufficiency Clinical Trial

Official title:
Innovation Against Infection - Device Related Infections - Part ETT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02284438
Other study ID # IMI-ETT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date February 2020

Study information
Verified date December 2018
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding formation and structure of the biofilm formed on those ETTs.

Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be examined.

Findings from electron microscopy (EM) and microbiology will be analyzed and compared in respect to the three materials.

Description:

Ventilator associated pneumonia (VAP) is a frequent and costly complication to mechanical ventilation in critically ill patients. Aspiration of oropharyngeal secretions and fragments of biofilm from the endotracheal tube are the main causes of VAP.

It is well known that biofilm is formed on medical devices and several initiatives to reduce the development of such biofilms have been taken. However it is still a large clinical problem and colleagues have performed studies to find out the structure of the biofilms formed on the ETT and to what extent microbiological findings correlate to images from EM.

In this study the investigators will compare microbiology and EM images in that same manner.

Three different ETTs will be examined. The investigators will be using each of the three ETTs for a period of time sufficient to retrieve samples from at least 20 ETTs of each kind.

Only one kind of ETT will be used during the specified time period, no randomization. The test will be performed in the order mentioned below A - B - C All of the three tubes are CE-marked (Conformité Européenne) and are available on the market.

ICU patients needing mechanical ventilation will be intubated with the three different devices with different surfaces characteristics.

The tubes are: A - standard Poly vinyl chloride (PVC) tube; B - PVC with a silicon coating; C - PVC with a special metal film coating

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date February 2020
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients needing invasive mechanical ventilation through an endotracheal tube

Exclusion Criteria:

- Anticipated need for mechanical ventilation less than 24 hours

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Endotracheal tube
Three endotracheal tubes with different surfaces will be used

Locations
Country Name City State
Sweden Intensive Care Unit, Lund University Hospital Lund

Sponsors (3)
Lead Sponsor Collaborator
Region Skane Bactiguard AB, Vinnova

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Gil-Perotin S, Ramirez P, Marti V, Sahuquillo JM, Gonzalez E, Calleja I, Menendez R, Bonastre J. Implications of endotracheal tube biofilm in ventilator-associated pneumonia response: a state of concept. Crit Care. 2012 May 23;16(3):R93. doi: 10.1186/cc11357. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube Pieces of the tubes examined with electron microscopy and assessed for microbes After finished mechanical ventilation and extubation; expected average time on mechanical ventilation 5 days
Secondary White Blood Cell count Blood samples taken daily From admission to extubation. Expected average 5 days
Secondary C reactive protein Blood samples taken daily From admission to extubation. Expected average 5 days
Secondary Length of stay, ICU and Hospital Length of stay in Hospital and for the ICU stay Three months from study inclusion
Secondary Survival For participating patients the status of survival or non survival at days 28 and 90 (three months) Three months from study inclusion
See also
  Status Clinical Trial Phase
Recruiting NCT05904652 - High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties N/A
Completed NCT04030208 - Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT02930525 - Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation N/A
Recruiting NCT02539732 - Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm
Enrolling by invitation NCT02290236 - Monitored Saturation Post-ICU N/A
Completed NCT02056119 - RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit N/A
Terminated NCT01583088 - Early Stage Amyotrophic Lateral Sclerosis Phrenic Stimulation Phase 3
Withdrawn NCT00990119 - High Flow Therapy (HFT) to Treat Respiratory Insufficiency in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT01411722 - Electrical Activity of the Diaphragm During the Weaning Period Phase 2
Completed NCT00741949 - Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF Phase 3
Recruiting NCT00339053 - Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair Phase 4
Recruiting NCT00187434 - Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP) N/A
Completed NCT02687802 - Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation
Not yet recruiting NCT05906030 - Diaphragm Dysfunction and Ultrasound Perioperatively
Completed NCT03850977 - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Completed NCT02845375 - Effect of Neuromuscular Blockade and Reversal on Breathing Phase 4
Recruiting NCT03309423 - Is Venous to Arterial Conversion (v-TAC) of Blood Gas Reliable in Critical Ill Patients in the ICU? N/A
Completed NCT04115969 - Outcome After Non-invasive Ventilation.

External Links