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NCT Number: NCT02816918

Extraluminal Use of the Bronchial Blocker of Univent Tube

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.

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Key information

Conditions

Therapeutic Procedural Complication

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

中国

Qinhuangdao, Hebei, 066000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. time for positioning

    Time frame: 15 min

Secondary outcomes

  1. frequency of malpositions

    Time frame: 5 min

  2. frequency of fiberoptic

    Time frame: 10 min

Sponsors and collaborators

Lead sponsor

The First Hospital of Qinhuangdao

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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