N/A
N=163
EZ-blocker Versus Left Sided Double Lumen Tube in Adult Patients for Thoracic Surgery
Thoracic Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03403192 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Number of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements — 13; 14; 14; 13 Number of replacements
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EZ-Blocker (Device); DLT (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements |
13; 14; 14; 13 | — |
| SECONDARY Time it Takes to Place for Double Lumen Tube (DLT) and EZ |
3.2; 3.3; 2.0; 2.6 | — |
| SECONDARY Quality of Lung Isolation Between Devices |
2.76; 2.70; 2.92; 2.83 | — |
| SECONDARY Side Effects of Devices |
0; 3; 5; 0 | — |
Summary
The objective of this study is to evaluate the positional stability and quality of lung isolation provided by the EZ-blocker compared to a DLT for both right and left sided thoracic surgery.
An additional objective will be to assess time to placement of both devices and other significant clinical differences between these two approaches to placement of the bronchial blocker (BB) including airway injury and post-operatives sore throat, post-operative hoarseness, Additionally we would like to examine the preoperative high resolution CT imaging data to determine if there are anatomic landmarks that may potentially inform the appropriateness or inappropriateness of choosing an EZ-blocker or left sided DLT.
Eligibility Criteria
Inclusion Criteria
- Patients greater than 18 and 80 years of age scheduled for thoracoscopic surgery or thoracotomy requiring lung isolation
- Patient presenting as an outpatient for elective thoracic surgery
- In patients scheduled for thoracic surgery.
Exclusion Criteria
- History of difficult airway/intubation
- Patients suspected to have a difficult airway.
- Morbid obesity BMI >39
- Pregnancy
- Emergency status of surgery
- Thoracic surgery requiring a right sided double lumen tube
Data sourced from ClinicalTrials.gov (NCT03403192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.