The Use of LMA-Proseal and Endobronchial Blocker for One Lung Anesthesia, Case Series

Completed

• Conditions: Anesthetic Technique; One-lung Ventilation
• Interventions: Device: Bronchial blocker (Coopdech, Arndt); Device: LMA-ProsealTM

• Registration Number: NCT02106273
• Lead Sponsor: Mahidol University

Brief Summary

An observational pilot study to determine the success rate of using LMA Proseal in conjuction with endobronchial blocker to provide one-lung anesthesia for thoracic surgery.

Detailed Description

The use of LMA has gained popularity secondary to benefits confirmed by many literatures. However, LMA is rarely used in thoracic surgery. To enable one-lung ventilation, the LMA need to be used with bronchial blocker. The use of this combination has been reported as a rescue technique in special clinical scenarios, i.e. patient with difficult airway. When used in patient with difficult airway, the LMA will be inserted until proper ventilation achieved, then endobronchial blocker will be subsequently placed through the LMA into the selected main bronchus. The success rate of the the bronchial blocker placement via properly placed LMA has never been studied. This pilot study was designed to evaluate the success rate, the quality of lung collapsed, the dislodgement or other associated problems including some minor complications i.e. postoperative dysphagia, sore throat hoarseness of voice.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Study First Submitted: 2014-03-30
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-03
• Last Update Submitted: 2014-04-03
• Study First Posted: 2014-04-08
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• thoracic surgery that needed one-lung ventilation

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Exclusion Criteria

patient with

• Restrictive lung disease that needed positive pressure ventilation > 30 cm.H2O
• Mass or hematoma in the mouth which obstruct LMA insertion
• Emergency surgery
• Pregnancy
• Severe infection or active pulmaonary tuberculosis
• Hemoptysis
• Pulmonary nodule > 20 cm. or bronchilal pathology
• Pneumonectomy or sleeve resection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bronchial blocker	Bronchial blocker (Coopdech, Arndt)	Pilot study to enroll ASA class I-III patients age between 18-70 years who undergoes thoracic surgery which require one-lung ventilation.
Bronchial blocker	LMA-ProsealTM	Pilot study to enroll ASA class I-III patients age between 18-70 years who undergoes thoracic surgery which require one-lung ventilation.

Primary Outcome Measures

Name	Time	Method
success rate	15 mintues	can provide one-lung ventilation within 15 mintues

Secondary Outcome Measures

Name	Time	Method
Time consuming in achieving one-lung anesthesia	15 mintues	Total time spent to place bronchial blocker into the selected main bronchus shall not exceed 15 minutes. If investigators failed, the study will be terminated and patient will receive appropriate conventional airway management.
Sorethroat	1 day	Patient self assessment scale as followed 0 - no sore throat; 1. - mild sore throat (no pain at rest, only with swallowing, does not require intervention); 2. - moderate sore throat (some discomfort at rest, more with swallowing - but does not need medications); 3. - severe sore throat (at rest, require analgesics for sore throat)
Hoarseness of voice	1 day	Patient assessment scale by visitor as followed 0 - no hoarseness of voice detected, normal voice.; 1. - some hoarseness of voice detected but able to speak in all octaves.; 2. - notable hoarseness of voice, unable to phonate in high pitch.; 3. - marked hoarseness of voice, unable to phonate
Difficulty swallowing	1 day	Patient self assessment and visitor assessment in scale as followed. 0 - no problem swallowing. no pain.; 1. - some sore throat (grade 1) with swallowing but able to swallowing both liquid and solid.; 2. - moderate swallowing limitation, only liquid or soft diet swallowing - unable to swallow solid food; 3. - marked swallowing limitation, patient prefers to fast due to pain associated with swallowing. Speech therapist/OT/PT consult to evaluation swallowing problems

Trial Locations

Locations (1)

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital; 🇹🇭 Bangkok, Thailand