Condition category
Cancer
Date applied
19/11/2016
Date assigned
26/01/2017
Last edited
26/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a procedure where a long tube (bronchoscope) is used to see inside the airways. Ultrasound is also used to allow doctors to take tissue samples from just outside the lungs. EBUS-TBNA is used to diagnose lung cancer. There are two common ways to access the airways: the traditional way uses a rigid bronchoscope while the newer way involves jet ventilation via a laryngeal mask, which is a less invasive artificial airway device. Until now nobody has investigated if these two types of ventilation for EBUS procedures are comparable. For both types of airway device a general anaesthetic is necessary but for rigid bronchoscopy muscle relaxants have to be used in order to avoid damage to the larynx (voice box) and the pharynx (throat). The use of muscle relaxants can result in a longer recovery time for the patients. The aim of this study is to compare these two types of jet ventilation during EBUS-TBNA.

Who can participate?
Patients at least 18 years old who are undergoing EBUS-TBNA for lung cancer staging or examination of lymph nodes

What does the study involve?
Patients are randomly allocated to be jet ventilated during EBUS-TBNA via either a laryngeal mask or a rigid bronchoscope. Treatment time varies and can last from 10 minutes to about 1 hour. The patients’ recovery after anesthesia is assessed until they are moved to the normal ward.

What are the possible benefits and risks of participating?
Both ventilation methods are well established and no new methods or drugs are tested in this study.

Where is the study run from?
1. Medical University of Vienna (Austria)
2. Karl Landsteiner Privatuniversität für Gesundheitswissenschaften (Austria)

When is the study starting and how long is it expected to run for?
October 2016 to November 2018

Who is funding the study?
Medical University of Vienna (Austria)

Who is the main contact?
Dr Maria Anwar

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Anwar

ORCID ID

Contact details

Währinger Gürtel 18-20
Vienna
1180
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1638/2016

Study information

Scientific title

A prospective randomized controlled trial examining infraglottic versus supraglottic superimposed high-frequency jet-ventilation in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration – a two-center experience

Acronym

Study hypothesis

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) under general anesthesia with supraglottic Jet-Ventilation using a laryngeal mask airway (LMA) with the Veres Adapter is not inferior to infraglottic Jet-Ventilation with rigid bronchoscopy regarding the outcome parameters.

Ethics approval

1. Ethikkommission der medizinischen Universität Wien, 10/08/2016, ref: 1638/2016
2. Ethikkommission für das Bundesland Niederösterreich, 16/09/2016, ref: GS4-EK-3/125-2016

Study design

Multicentre prospective randomized 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 to request a participant information sheet

Condition

EBUS-TBNA +/- tumour biopsy

Intervention

Patients are randomised to be ventilated with either:
1. Jet ventilation via a LMA with a jet converter
2. Jet ventilation via a rigid bronchoscope (traditional method)

Treatment time varies and lasts from 10 minutes to about 1 hour. For both treatments the Aldrete score at the Post Anesthesia Care Unit (PACU) is recorded. The observation for the patient ends when they are transferred from the PACU to the normal ward.

Intervention type

Phase

Drug names

Primary outcome measures

Recovery after anesthesia, measured using the Aldrete score every 10 minutes for the first hour after admission to the PACU, every 15 minutes for the second hour, and every 30 minutes for the third hour

Secondary outcome measures

1. Time from anesthesia start until the end of the procedure
2. Anesthesia recovery time, defined as the time from the end of the procedure with removal of the bronchoscope until removal of the laryngeal mask
3. Diagnostic yield of EBUS-TBNA, defined as the percentage of patients for whom the procedure rendered a specific diagnosis
4. Device-related complications such as incorrect position of the LMA leading to difficulties in ventilation and gastric insufflation, difficulties to insert the rigid bronchoscope and excessive coughing that delays the procedure and requires additional medication
5. Anesthesia-related complications such as hypotension (defined as a drop in systolic blood pressure < 90 mmHg requiring intervention such as vasopressors or fluid), hypertension (an increase in mean arterial pressure > 30% from baseline longer than 5 minutes), hypoxemia (oxygen saturation < 90% for more than 1 minute), hypercarbia (PtcCO2 > 50 mmHg for more than 1 minute) and arrhythmia requiring antiarrhythmic medication
6. Severe EBUS-related complications such as bleeding, pneumothorax and mediastinitis
Measured throughout admission to the PACU

Overall trial start date

03/10/2016

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients requiring EBUS-TBNA for lung cancer staging or examination of suspect mediastinal or hilar lymph nodes (at least one needle aspiration), puncture of a maximum of four lymph node stations +/- or even tumour biopsy
2. Obtained informed consent
3. At least 18 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90 patients in two groups in two centers. Group 1 = LMA+SHFJV; Group 2 = Rigid bronchoscopy+SHFJV. 45 patients per center. Group 1 includes 30 patients and Group 2 includes 15 patients per center.

Participant exclusion criteria

1. Less than 18 years old
2. Pregnancy
3. Patients allergic to involved anesthetic agents
4. Patients presenting contraindications for the use of either of the two methods
5. Patients with known presence of atypical Pseudocholinesterase
6. Mediastinal mass tumors (larger than 10cm in diameter) which might compress the mediastinal vessels
7. Known severe heart failure (NYHA III+IV)
8. Patient will be transferred to the ICU after the procedure
9. Drug abuse
10. Lack of English or German language skills
11. GCS < 12
12. Severe neurologic disease that hinders postoperative assessment
13. Informed consent not obtained
14. Patients with emergency procedures
15. Patients with infections mediastinitis

Recruitment start date

03/10/2016

Recruitment end date

30/11/2018

Locations

Countries of recruitment

Austria

Trial participating centre

Medical University of Vienna
Währinger Gürtel 18-20
Vienna
1090
Austria

Trial participating centre

Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
Mitterweg 10
Krems an der Donau
3500
Austria

Sponsor information

Organisation

Medical University of Vienna

Sponsor details

Währinger Gürtel 18-20
Vienna
1090
Austria

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Medical University of Vienna

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results and statistical analysis will be published in a top anaesthesiological journal.

IPD sharing plan
Patient data will not be published for the reasons of confidence. Only aggregated data will be published.
Data will be collected and stored in order to grant access only to authorized persons.

Intention to publish date

30/11/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes