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NCT Number: NCT02106273

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.

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Key information

Conditions

Anesthetic Technique One-Lung Ventilation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bronchial blocker (Coopdech, Arndt)

Device

Using bronchial blocker with LMA

Other names: Coopdech, Arndt

LMA-ProsealTM

Device

Primary outcomes

  1. success rate

    Time frame: 15 mintues

    can provide one-lung ventilation within 15 mintues

Secondary outcomes

  1. Time consuming in achieving one-lung anesthesia

    Time frame: 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.

  2. Sorethroat

    Time frame: 1 day

    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)

  3. Hoarseness of voice

    Time frame: 1 day

    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

  4. Difficulty swallowing

    Time frame: 1 day

    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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 8, 2014
Registry last updated
Apr 8, 2014

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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