Extraluminal Use of the Bronchial Blocker of Univent Tube

Therapeutic Procedural Complication Clinical Trial

Official title:

Extraluminal Use of the Bronchial Blocker of Univent Tube During Adult One-lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816918
• Other study ID #: 995866
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2016
• Last updated: December 6, 2016
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: The First Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Therapeutic Procedural Complication

Intervention

Device:
• Extraluminal use of Univent bronchial Blocker
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
• Innerluminal use Univent bronchial Blocker
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

Locations

Country	Name	City	State
China	??	Qinhuangdao	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time for positioning		15 min
Secondary	frequency of malpositions		5 min
Secondary	frequency of fiberoptic		10 min