Anesthetic TechniqueNCT02106273
The Use of LMA-Proseal and Endobronchial Blocker for One Lung Anesthesia, Case Series
An observational study of Anesthetic Technique and One-lung Ventilation, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthetic Technique, One-lung Ventilation
- What is being tested?
- Bronchial blocker (Coopdech, Arndt) and LMA-ProsealTM
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA class I-III patients age 18-75 years scheduled for thoracic surgery that required one-lung ventilation
Who may be able to join
- 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
Show all 9Show fewer
- Hemoptysis
- Pulmonary nodule > 20 cm. or bronchilal pathology
- Pneumonectomy or sleeve resection
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
Bangkok, 10700
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthetic Technique, One-lung Ventilation
- Being tested
- Bronchial blocker (Coopdech, Arndt), LMA-ProsealTM
- Keywords
- LMA, Bronchial blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial blocker (Coopdech, Arndt)Device
Also called Coopdech, Arndt
Using bronchial blocker with LMA
LMA-ProsealTMDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bronchial blocker (Coopdech, Arndt); Device: LMA-ProsealTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
can provide one-lung ventilation within 15 mintues
Measured: 15 mintues
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetic TechniqueStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prasert Sawasdiwipachai, Mahidol University
- Investigators
- Prasert Sawasdiwipachai, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106273
- Sponsor's protocol ID
- Si154/2011
- Status last verified
- Apr 2014
- First submitted
- 30 Mar 2014
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of LMA-Proseal and Endobronchial Blocker for One Lung Anesthesia, Case Series.
- ClinicalTrials.gov ID
- NCT02106273
- Acronym / sponsor ID
- Si154/2011
- Conditions
- Anesthetic Technique, One-lung Ventilation
- Keywords
- LMA, Bronchial blocker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchial blocker | – | Device: Bronchial blocker (Coopdech, Arndt), Device: LMA-ProsealTMPilot study to enroll ASA class I-III patients age between 18-70 years who undergoes thoracic surgery which require one-lung ventilation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA class I-III patients age 18-75 years scheduled for thoracic surgery that required one-lung ventilation
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchial blocker (Coopdech, Arndt)Also: Coopdech, ArndtUsing bronchial blocker with LMA | Device | Bronchial blocker |
| LMA-ProsealTM | Device | Bronchial blocker |
Primary outcome
success rate
Time frame: 15 mintues
can provide one-lung ventilation within 15 mintues
4 secondary outcomes
Time consuming in achieving one-lung anesthesia
Time frame: 15 mintues
Sorethroat
Time frame: 1 day
Hoarseness of voice
Time frame: 1 day
Difficulty swallowing
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
Related trials for Anesthetic Technique
Recruiting
Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study
Pulmonary Aspiration, Emergency Surgery
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Recruiting
Comparison of Different Anesthetic Techniques on Hearing Outcomes in Neonates After Cesarean Delivery
Pregnancy, Neonatal Hearing Function
Active, not recruiting
Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement.
Dental Implants, Local Anesthesia
RecruitingPhase 4
Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)
Hemodynamic Response
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasert Sawasdiwipachai, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthetic Technique and One-lung Ventilation, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: 15 mintues). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.