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Extraluminal Use of the Bronchial Blocker of Univent Tube

T

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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