Bronchial Blocker for One-lung Ventilation in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Complication of Ventilation Therapy Intubation Complication Postoperative; Dysfunction Following Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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DLT group

In this arm, patient will be intubated with a double lumen endotracheal tube

Group Type ACTIVE_COMPARATOR

double-lumen endotracheal tube (DLT group)

Intervention Type DEVICE

In this arm, after anesthesia induction, a double lumen endotracheal tube will be intubated for one-lung ventilation

BB group

In this arm, patient will be intubated with an endobronchial blocker

Group Type EXPERIMENTAL

endobronchial blocker (BB group)

Intervention Type DEVICE

In this arm, after anesthesia induction, an endobronchial blocker will be intubated for one-lung ventilation

Interventions

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double-lumen endotracheal tube (DLT group)

In this arm, after anesthesia induction, a double lumen endotracheal tube will be intubated for one-lung ventilation

Intervention Type DEVICE

endobronchial blocker (BB group)

In this arm, after anesthesia induction, an endobronchial blocker will be intubated for one-lung ventilation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No