Extraluminal Use of the Bronchial Blocker of Univent Tube

NCT02816918 | Completed Phase 1 DMC

• 1 other identifier: 995866
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Therapeutic Procedural Complication

Outcome Measures

Primary Outcomes (1)

• time for positioning

  15 min

Secondary Outcomes (2)

• frequency of malpositions

  5 min

• frequency of fiberoptic

  10 min

Study Arms (2)

Extraluminal use of Univent Blocker

EXPERIMENTAL

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

Innerluminal use of Univent Blocker

EXPERIMENTAL

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

Interventions

Extraluminal use of Univent bronchial Blocker DEVICE

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

Extraluminal use of Univent Blocker

Innerluminal use Univent bronchial Blocker DEVICE

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

Innerluminal use of Univent Blocker

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Qinhuangdao: lead

Study Sites (1)

中国

Qinhuangdao, Hebei, 066000, China

Location

Study Officials

• Ximing Qi

  The First Hospital of Qinhuangdao

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 29, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)