Bronchial Blocker for One-lung Ventilation in Cardiac Surgery

March 31, 2016 updated by: HailongDong, Xijing Hospital

The Use of Bronchial Blocker Versus Double Lumen Tube for One-lung Ventilation During Thoracoscope Assisted Mitral Valve Replacement

To investigate if bronchial blocker is more suitable for one-lung ventilation during thoracoscope assisted mitral valve replacement surgery with Cardiopulmonary Bypass than the double-lumen endobronchial tube.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Postoperative hoarseness, sore throat, and vocal cord injuries are common complications after general anesthesia. The incidence of postoperative hoarseness is as frequent as 50% after short-term tracheal intubation. In the past, several risk factors for postoperative hoarseness and laryngeal injury have been identified, including demographic factors, quality of tracheal intubation and technical factors such as endotracheal tube size. One-lung ventilation during thoracotomy can be achieved via two basic techniques: (1) use of a double-lumen endotracheal tube (DLT) consisting of an endotracheal and an endobronchial lumen allowing independent single-lung ventilation ; or (2) use of an endobronchial blocker such as the Arndt blocker, which allows lung collapse distal to the occlusion. It has been recently demonstrated that DLT and endobronchial blocker are similar in their efficacy to achieve lung isolation for elective thoracic surgery. No data are available yet about the influence of the chosen technique on postoperative hoarseness, vocal cord injuries, sore throat, and bronchial injuries. Published data of Stout et al. imply that the incidence of postoperative hoarseness and vocal cord injury might be directly correlated with size of the used endotracheal tube. During thoracoscope assisted mitral valve replacement cardiac surgery, excellent lung isolated was not required. One-lung ventilation with the other lung collapsed is used to achieve a better exposure and assist the surgery. During the cardiac surgery under cardiopulmonary bypass, heparinization will lead to uncontrolled hemorrhage if there is endotracheal tube insertion associated injury. In addition, DLTs need to be exchanged for a single-lumen tube before the patient transferring to cardiac care unit for postoperative ventilatory support. This may result in second time injury. Investigators hypothesized that using a bronchial blocker to achieve one-lung ventilation may result in a lower incidence of clinically relevant laryngeal and bronchial morbidity after thoracoscope assisted mitral valve replacement cardiac surgery compared with a control group intubated with a DLT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact

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Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. New York Heart Association (NYHA)I-III level.
  2. scheduled for thoracoscope assisted mitral valve surgery under surgery
  3. provide with informed consent.

Exclusion Criteria:

  1. emergency surgery.
  2. preoperative pulmonary diseases, such as chronic obstructive pulmonary disease, atelectasis.
  3. preoperative voice hoarse or sore throat.
  4. involved in other clinical trials within 3 months .
  5. Cannot cooperate with language understanding disorders or psychological problems.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: DLT group
In this arm, patient will be intubated with a double lumen endotracheal tube
Device: double-lumen endotracheal tube (DLT group)
In this arm, after anesthesia induction, a double lumen endotracheal tube will be intubated for one-lung ventilation
Experimental: BB group
In this arm, patient will be intubated with an endobronchial blocker
Device: endobronchial blocker (BB group)
In this arm, after anesthesia induction, an endobronchial blocker will be intubated for one-lung ventilation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
clinically relevant laryngeal and bronchial morbidity
Time Frame: perioperative period
incidence of clinically relevant laryngeal and bronchial morbidity will be recorded, including postoperative hoarseness, sore throat, and vocal cord injuries, pulmonary complications
perioperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: perioperative period
Heart rate in BPM will be recorded at right before intubation (T1), at intubation (T2), and at three minutes after intubation (T3).
perioperative period
Central Venous Pressure
Time Frame: perioperative period
Central venous pressure in cmH2O will be recorded at right before intubation (T1),at intubation (T2), and at three minutes after intubation (T3).
perioperative period
Blood Pressure
Time Frame: perioperative period
Systolic blood pressure, diastolic blood pressure and mean arterial pressure all in mmHg will be recorded at right before intubation (T1),at intubation (T2), and at three minutes after intubation (T3).
perioperative period
the Duration of Ventilation
Time Frame: The duration of ventilation in minutes will be recorded at time from intubation to extubation, an expected average of 18 hours.
It is the duration of ventilation, prolonged ventilation is defined as patients remaining on the ventilator for more than 48 hours
The duration of ventilation in minutes will be recorded at time from intubation to extubation, an expected average of 18 hours.
Length of Postoperative Hospital Stay
Time Frame: Length of postoperative hospital stay in days will be recorded which is defined as the time from surgery to hospital discharge, an expected average of 10 days
Recorded the time of postoperative hospital stay in days.
Length of postoperative hospital stay in days will be recorded which is defined as the time from surgery to hospital discharge, an expected average of 10 days
Length of CCU Stay
Time Frame: Length of CCU stay in hours will be recorded which is defined as the time stay in the cardiac intensive care unit, an expected average of 3 days.
It is the length of stay in cardiac ICU
Length of CCU stay in hours will be recorded which is defined as the time stay in the cardiac intensive care unit, an expected average of 3 days.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hailong Dong, MD & PhD, Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20153001-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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