Comparing different types of jet ventilation during endobronchial ultrasound guided transbronchial needle aspiration
| ISRCTN | ISRCTN58911367 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58911367 |
| Secondary identifying numbers | 1638/2016 |
- Submission date
- 19/11/2016
- Registration date
- 26/01/2017
- Last edited
- 27/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Währinger Gürtel 18-20
Vienna
1180
Austria
Study information
| Study design | Multicentre prospective randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 03/10/2016 |
| Completion date | 30/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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. |
| Total final enrolment | 90 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/10/2016 |
| Date of final enrolment | 18/01/2018 |
Locations
Countries of recruitment
- Austria
Study participating centres
Vienna
1090
Austria
Krems an der Donau
3500
Austria
Sponsor information
University/education
Währinger Gürtel 18-20
Vienna
1090
Austria
"ROR" |
https://ror.org/05n3x4p02 |
|---|
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Medical University of Vienna, MediUni Wien
- Location
- Austria
Results and Publications
| Intention to publish date | 30/11/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2020 | 27/05/2020 | Yes | No |
Editorial Notes
27/05/2020: Publication reference and total final enrolment number added.
10/04/2018: The recruitment end date was changed from 30/11/2018 to 18/01/2018.
