NCT02032342

Brief Summary

Selective lobar blockade (SLB) is a specific technique that allows collapse of the operated lobe during thoracic surgery while the other lobes are ventilated. It is associated with the improvement of arterial oxygenation during one lung ventilation (OLV) for thoracic with providing adequate surgical access. The purpose of this study is to compare the efficacy of three bronchial blockers, namely an Arndt® wire-guided endobronchial blocker, a Cohen Flexi-tip endobronchial blocker or a Fuji Uni-blocker, for achieving selective lobar collapse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

2.6 years

First QC Date

January 7, 2014

Last Update Submit

May 22, 2018

Conditions

Elective Thoracic SurgeryOne Lung Ventilation

Outcome Measures

Primary Outcomes (1)

  • operative field conditions

    The surgeons will be asked to rate the deflation of the target lung lobe using a 100-mm visual analog scale (VAS) (0: full inflated; 100: completely deflated).

    participants will be followed for the duration of surgery, an expected average of 3 hours

Secondary Outcomes (7)

  • time required to initially position the assigned device

    up to 8 minutes after position the assigned device

  • number of intraoperative FOB examinations

    for 2 hours after start of surgery

  • number of lung isolation device malpositionings

    for 2 hours after start of surgery

  • Arterial oxygenation

    5 min after induction, 15 min after start of one lung ventilation, 30 min after start of one lung ventilation, 60 min after start of one lung ventilation

  • Heart rate

    5 min after induction, 15 min after start of one lung ventilation, 30 min after start of one lung ventilation, 60 min after start of one lung ventilation

  • +2 more secondary outcomes

Study Arms (4)

Fuji Uni-blocker

ACTIVE COMPARATOR

Fuji Uni-blocker for selective lobar deflation

Device: Fuji Uni-blocker

Cohen blocker

ACTIVE COMPARATOR

Cohen blocker for selective lobar deflation

Device: Cohen blocker

Arndt® blocker

ACTIVE COMPARATOR

Arndt® blocker for selective lobar deflation

Device: Arndt® blocker

Endobronchial double lumen tube

PLACEBO COMPARATOR

Endobronchial double lumen tube for one lung ventilation

Device: Endobronchial double lumen tube

Interventions

Endobronchial double lumen tubeDEVICE

Endobronchial double lumen tube for one lug ventilation

Endobronchial double lumen tube
Arndt® blockerDEVICE

Arndt® blocker for selective lobar deflation

Arndt® blocker
Cohen blockerDEVICE

Cohen blocker for selective lobar deflation

Cohen blocker
Fuji Uni-blockerDEVICE

Fuji Uni-blocker foe selective lobar deflation

Fuji Uni-blocker

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists physical class of II to III
  • Elective thoracic surgery
  • no previous thoracic surgery on the operation
  • the lung lobe containing or adjacent to the lesion can be targeted for collapse

You may not qualify if:

  • emergency procedures
  • pneumonectomy
  • bilobectomy
  • history of infectious lesions
  • history of bleeding lung lesions
  • tracheotomy
  • Body mass index \> 35 kg/m2
  • difficult airways

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dammam University

Khobar, Eastern Province, 31952, Saudi Arabia

Location

Study Officials

  • Abdulmohsen Al Ghamdi, MD

    Associate Professor, of Anesthesia and Surgical ICU, University of Dammam, Al Khubar, Saudi Arabia

    STUDY CHAIR

  • Mohammed Abdul Shafi, MD

    Assistant Professor of Anesthesia and Surgical ICU, University of Dammam, Al Khubar, Saudi Arabia.

    STUDY CHAIR

  • Haytham Zien, MD

    Assistant Professor of Anesthesia and Surgical ICU, Dammam University

    STUDY CHAIR

  • Alaa M Khidr, MD

    Assistant Professor Anaesthesiology and Surgical ICU, King Fahd Hospital of the University of Dammam, Al Khubar, Saudi Arabia

    STUDY CHAIR

  • Yasser F El Ghoneimy, MD

    Associate Professor of Cardiothoracic Surgery, King Fahd Hospital of the University of Dammam, Al Khubar, Saudi Arabia.

    STUDY CHAIR

  • Mohamed A Regal, MD

    Associate Professor of Cardiothoracic Surgery, King Fahd Hospital of the University of Dammam, Al Khubar, Saudi Arabia.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 10, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

SA(1)