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Comparing different types of jet ventilation during endobronchial ultrasound guided transbronchial needle aspiration

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58911367
Enrollment
90
Registered
2017-01-26
Start date
2016-10-03
Completion date
Unknown
Last updated
2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EBUS-TBNA +/- tumour biopsy Cancer

Interventions

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)

Sponsors

Medical University of Vienna
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 30% from baseline longer than 5 minutes), hypoxemia (oxygen saturation 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

Countries

Austria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026