Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Application of Bronchial Blocker in Minimally Invasive Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03505242
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
Both left single lung ventilation by left double lumen tube and bilateral ventilation with selective blockage of right middle lower lobe by bronchial blocker can provide suitable surgical field for minimally invasive cardiac surgery. The current study was designed to compare the impact of these two different methods on oxygenation, degree of pulmonary collapse and postoperative complications.

Condition or disease Intervention/treatment Phase
Minimally Invasive Cardiac Surgery Device: bronchial blocker for BB group Device: double lumen tube for DLT group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bronchial Blocker in Blocking the Right Middle Lower Lobe Versus Double-Lumen Endotracheal Tube for One-Lung Ventilation in Minimally Invasive Cardiac Surgery
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: BB Device: bronchial blocker for BB group
Using bronchial blocker to block right middle lower lobe during surgery.

Experimental: DLT Device: double lumen tube for DLT group
Using double lumen tube to achieve single lung ventilation during surgery.




Primary Outcome Measures :
  1. oxygenation [ Time Frame: intraoperative ]
    record SpO2 and PaO2 during selective ventilation


Secondary Outcome Measures :
  1. degree of pulmonary collapse [ Time Frame: intraoperative ]
    surgeon score the degree of pulmonary collapse (1 for no pulmonary collapse and 5 for excellent pulmonary collapse)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA II-III
  • BMI 18-31
  • elective minimally invasive cardiac surgery by right thoracotomy

Exclusion Criteria:

  • asthma
  • COPD
  • previous lung surgery
  • previous cardiac surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505242


Contacts
Layout table for location contacts
Contact: Kefang Guo +8613817706936 guo.kefang@zs-hospital.sh.cn
Contact: Lin Jin +8613917131195 jin.lin@zs-hospital.sh.cn

Sponsors and Collaborators
Shanghai Zhongshan Hospital

Layout table for additonal information
Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03505242     History of Changes
Other Study ID Numbers: ABMICS
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No