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

One-lung Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106273
• Other study ID #: Si154/2011
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2014
• Last updated: April 3, 2014
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthetic Technique
• One-lung Ventilation

Intervention

Device:
• Bronchial blocker (Coopdech, Arndt)
Using bronchial blocker with LMA
• LMA-ProsealTM

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate	can provide one-lung ventilation within 15 mintues	15 mintues	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes