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Register:	ISRCTN
Last refreshed on:	8 June 2020
Main ID:	ISRCTN58911367
Date of registration:	26/01/2017
Prospective Registration:	No
Primary sponsor:	Medical University of Vienna
Public title:	Comparing different types of jet ventilation during endobronchial ultrasound guided transbronchial needle aspiration
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
Date of first enrolment:	03/10/2016
Target sample size:	90
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN58911367
Study type:	Interventional
Study design:	Multicentre prospective randomized trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Austria

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Maria Anwar
Address:	Währinger Gürtel 18-20 1180 Vienna Austria
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

EBUS-TBNA +/- tumour biopsy
Cancer

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

1638/2016

Source(s) of Monetary Support

Medizinische Universität Wien

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	30/11/2018
URL:

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