Extraluminal Use of the Bronchial Blocker of Univent Tube

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

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.

Study Overview

• Status: Completed
• Conditions: Therapeutic Procedural Complication
• Intervention / Treatment: Device: Extraluminal use of Univent bronchial Blocker; Device: Innerluminal use Univent bronchial Blocker

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • 中国

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Extraluminal use of Univent 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	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
EXPERIMENTAL: Innerluminal use of Univent 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time for positioning	15 min

Secondary Outcome Measures

Outcome Measure	Time Frame
frequency of malpositions	5 min
frequency of fiberoptic	10 min

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 26, 2016
• First Posted (ESTIMATE): June 29, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 995866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES