Bronchial Blocker for One-lung Ventilation in Cardiac Surgery

Phase 4

• Conditions: Complication of Ventilation Therapy; Intubation Complication; Postoperative; Dysfunction Following Cardiac Surgery
• Interventions: Device: endobronchial blocker (BB group); Device: double-lumen endotracheal tube (DLT group)

• Registration Number: NCT02729610
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-31
• Last Update Submitted: 2016-03-31
• Study First Posted: 2016-04-06
• Last Update Posted: 2016-04-06
• Primary Completion: 2016-09
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BB group	endobronchial blocker (BB group)	In this arm, patient will be intubated with an endobronchial blocker
DLT group	double-lumen endotracheal tube (DLT group)	In this arm, patient will be intubated with a double lumen endotracheal tube

Primary Outcome Measures

Name	Time	Method
clinically relevant laryngeal and bronchial morbidity	perioperative period	incidence of clinically relevant laryngeal and bronchial morbidity will be recorded, including postoperative hoarseness, sore throat, and vocal cord injuries, pulmonary complications

Secondary Outcome Measures

Name	Time	Method
Central Venous Pressure	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).
Blood Pressure	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).
Length of Postoperative Hospital Stay	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.
the Duration of Ventilation	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
Heart Rate	perioperative period	Heart rate in BPM will be recorded at right before intubation (T1), at intubation (T2), and at three minutes after intubation (T3).
Length of CCU Stay	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