Extraluminal Use of the Bronchial Blocker of Univent Tube

The First Hospital of Qinhuangdao

Status and phase: Completed; Phase 1

Conditions: Therapeutic Procedural Complication

Treatments: Device: Innerluminal use Univent bronchial Blocker; Device: Extraluminal use of Univent bronchial Blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT02816918

995866

Details and patient eligibility

About

intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.

Full description

One-lung ventilation is desirable for Several clinical procedures, such as thoracic,pulmonary, and cardiac surgery to facilitate lung exposure for these surgical procedures by collapsing the lung and most commonly used device is the double-lumen tube (DLT) for this surgical procedures.Bronchial blockers (BBs), such as univent tube with an bronchial Blocker, has more advantages than the double-lumen tube: no need exchange tube when mechanical ventilation is required postoperative, easier insertion,less postoperative sore throat (ST) and hoarseness. However, BBs requires more time for placement and more difficult to position, especially patients undergoing left-side thoracic surgery. So, this study intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• sixty patients undergoing left thoracic surgery
• ASA classifications of I-II, modified Mallampati classification of 1 or 2, requiring general anesthesia were included.

Exclusion criteria

• age younger than 18 yr or older than 70 yr
• BMI>30 kg/m2
• with upper respiratory tract infection,asthma
• Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Extraluminal use of Univent Blocker

Experimental group

Description:

Patients assigned to the Extraluminal use of Univent Blocker group were first inserted Univent bronchial Blocker into the glottis via direct laryngoscopy then advanced the Blocker to the target bronchus until slight resistance was encountered.A conventional tracheal tube with appropriate size was intubated via direct laryngoscopy into the appropriate depth, inflating the tracheal tube cuff, and fixing the tube firmly at the patient's mouth with cloth tape . So the Univent Blocker Extraluminal of the endotracheal tube,then the fibreoptic bronchoscopy was inserted into the tracheal tube and guided bronchial blocker cuff to the target main bronchus under direct vision

Treatment:

Device: Extraluminal use of Univent bronchial Blocker

Innerluminal use of Univent Blocker

Experimental group

Description:

Patients in Innerluminal use of Univent Blocker group: When the endotracheal tube had been intubated via direct laryngoscopy, the bronchial blocker was advanced Innerluminal of the endotracheal tube and directed into the right or left mainstem bronchus, then the fibreoptic bronchoscopy was inserted into the tracheal tube. After further pushing and twisting, the bronchial blocker tube will move into the mainstem bronchus under direct vision by FOB.the tracheal tube cuff is inflated with the tube being fixed firmly at the patient's mouth with cloth tape

Treatment:

Device: Innerluminal use Univent bronchial Blocker