Application of Bronchial Blocker in Minimally Invasive Cardiac Surgery

April 12, 2018 updated by: Shanghai Zhongshan Hospital

Bronchial Blocker in Blocking the Right Middle Lower Lobe Versus Double-Lumen Endotracheal Tube for One-Lung Ventilation in Minimally Invasive Cardiac Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxygenation
Time Frame: intraoperative
record SpO2 and PaO2 during selective ventilation
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ABMICS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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