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Bronchial Blocker for One-lung Ventilation in Cardiac Surgery

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02729610
Enrollment
58
Registered
2016-04-06
Start date
2016-03-31
Completion date
2016-10-31
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEdouble-lumen endotracheal tube (DLT group)

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

DEVICEendobronchial blocker (BB group)

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

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
clinically relevant laryngeal and bronchial morbidityperioperative periodincidence of clinically relevant laryngeal and bronchial morbidity will be recorded, including postoperative hoarseness, sore throat, and vocal cord injuries, pulmonary complications

Secondary

MeasureTime frameDescription
Central Venous Pressureperioperative periodCentral venous pressure in cmH2O will be recorded at right before intubation (T1),at intubation (T2), and at three minutes after intubation (T3).
Blood Pressureperioperative periodSystolic 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).
Heart Rateperioperative periodHeart rate in BPM will be recorded at right before intubation (T1), at intubation (T2), and at three minutes after intubation (T3).
Length of Postoperative Hospital StayLength 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 daysRecorded the time of postoperative hospital stay in days.
Length of CCU StayLength 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
the Duration of VentilationThe 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

Contacts

Primary ContactHailong Dong, MD & PhD
hldong6@hotmail.com86-29-84775337
Backup ContactChong Lei, MD & PhD
leichongbb@gmail.com86-29-84775337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026