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

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

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.

Study Overview

• Status: Completed
• Conditions: One-lung Ventilation; Anesthetic Technique
• Intervention / Treatment: Device: Bronchial blocker (Coopdech, Arndt); Device: LMA-ProsealTM

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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ASA class I-III patients age 18-75 years scheduled for thoracic surgery that required one-lung ventilation

Description

Inclusion Criteria:

• thoracic surgery that needed one-lung ventilation 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bronchial blocker; Pilot study to enroll ASA class I-III patients age between 18-70 years who undergoes thoracic surgery which require one-lung ventilation.	Device: Bronchial blocker (Coopdech, Arndt); Using bronchial blocker with LMA; Other Names: Coopdech; Arndt; Device: LMA-ProsealTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	can provide one-lung ventilation within 15 mintues	15 mintues

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time consuming in achieving one-lung anesthesia	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.	15 mintues
Sorethroat	Patient self assessment scale as followed 0 - no sore throat; - mild sore throat (no pain at rest, only with swallowing, does not require intervention); - moderate sore throat (some discomfort at rest, more with swallowing - but does not need medications); - severe sore throat (at rest, require analgesics for sore throat)	1 day
Hoarseness of voice	Patient assessment scale by visitor as followed 0 - no hoarseness of voice detected, normal voice.; - some hoarseness of voice detected but able to speak in all octaves.; - notable hoarseness of voice, unable to phonate in high pitch.; - marked hoarseness of voice, unable to phonate	1 day
Difficulty swallowing	Patient self assessment and visitor assessment in scale as followed. 0 - no problem swallowing. no pain.; - some sore throat (grade 1) with swallowing but able to swallowing both liquid and solid.; - moderate swallowing limitation, only liquid or soft diet swallowing - unable to swallow solid food; - marked swallowing limitation, patient prefers to fast due to pain associated with swallowing. Speech therapist/OT/PT consult to evaluation swallowing problems	1 day

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 30, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): April 8, 2014
• Last Update Submitted That Met QC Criteria: April 3, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Bronchial blocker; LMA
• Other Study ID Numbers: Si154/2011