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Prospective randomized controlled trial for qualitative comparison between the double lumen tube and the bronchus blocker "EZ-blocker Endobronchial Blocker®" (Teleflex Life Sciences) for one-lung ventilation during thoracic surgery

Prospective randomized controlled trial for qualitative comparison between the double lumen tube and the bronchus blocker "EZ-blocker Endobronchial Blocker®" (Teleflex Life Sciences) for one-lung ventilation during thoracic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014816
Enrollment
80
Registered
2018-06-07
Start date
2018-06-11
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

process times, quality of lung lung collapse T88.4

Interventions

Group 1: one-lung ventilation achieved by double lumen tube Group 2: one-lung ventilation achieved by combination of single lumen tube plus bronchus blocker model "EZ-Blocker"

Sponsors

Klinik für Anästhesie und Intensivmedizin, Universitätsklinikum Gießen und Marburg, Standort Marburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing elective thoracic surgery and for what DLT-intubation for one-lung ventilation is required

Exclusion criteria

Exclusion criteria: - patients who did not consent to the study - pregnant patients - patients who have not reached the age of 18 years - patients with indications for so-called "rapid sequence induction" - patients who have a contraindication to one-lung ventilation - patients with severe cervical spine movement restriction, e.g. ankylosing spondylitis - patients who are not capable to consent

Design outcomes

Primary

MeasureTime frame
The primary endpoint is time to achieve lungseparation

Secondary

MeasureTime frame
other endpoints are: - primary intubation success, documented by a case report form; - quality of pulmonary collapse during one-lung ventilation by the blinded surgeon at the end of the operation using a standardized 3-item questionnaire; - different process times during the anesthesia initiation phase: material preparation; intubation using DLT, SLT, placement EZ-Blocker; bronchoscopy time for placement control of DLT or SLT/EZ-Blocker the occurrence and extent of intubation damage. Intubation damage is documented immediately before the end of the respective surgery by video laryngoscope (supraglottic) and by bronchoscope (subglottic). On the first day postoperatively, a follow-up examination by means of a flexible endoscope (supraglottic) is also carried out with electronic image documentation. The evaluation is carried out in the further course by blinded study physicians. A patient survey is also carried out using a questionnaire derived from the validated QLQ-H & N35 questionnaire module for diseases of the head and neck area.

Countries

Germany

Contacts

Public ContactCarsten Feldmann

Klinik für Anästhesie und Intensivmedizin, Universitätsklinikum Marburg

carsten.feldmann@uni-marburg.de+4964215865980

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 12, 2026