Complications, PulmonaryNCT05253404
Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy
A study testing Ambu® AuraOnce™ Disposable Laryngeal Mask in people with Complications, Pulmonary, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Stabilizing hemodynamic and reducing pulmonary complications during extubation with switching endotracheal tube to laryngeal mask in craniotomies Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Complications, Pulmonary
- What is being tested?
- Ambu® AuraOnce™ Disposable Laryngeal Mask
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2022to 9 Sep 2022
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA: 1-3, 20-65 years old undergoing craniotomies under general anesthesia
Who cannot join
- Decline to participated
- Difficult airway
- Body Mass Index >30
- Pregnant woman
- Nothing Per Os <8hrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Study
Stabilizing hemodynamic and reducing pulmonary complications during extubation with switching endotracheal tube to laryngeal mask in craniotomies
Read the detailed description
recruit ASA: 1-3, 20-65 years old undergoing neurosurgery under general anesthesia Excluded 1.Decline to participated 2.Difficult airway 3.Body Mass Index >30 4. Pregnant woman 5.Nothing Per Os <8hrs(case number:80).
General anesthesia Induction: 0.15-0.2 mg/kg cisatracurium or 0.6-1.2mg rocuronium , 1.5-2 mg/kg propofol, 1-2 mcg/kg Fentanyl. Endotracheal tube 6.5-7.5mm. Maintenance with sevoflurane 2- 3% FiO2:100%. Optimal muscle tension monitor. When surgery done, sevoflurane at 2.63-2.97%
Then randomly assigned two group Anesthesia group(control group) : Removed endotracheal tube at sevoflurane at 2-3% Switching group (intervention group): Intervention with endotracheal tube to laryngeal mask, and removing laryngeal mask at sevoflurane: 0.4MAC
- Conditions
- Complications, Pulmonary
- Being tested
- Ambu® AuraOnce™ Disposable Laryngeal Mask
- Keywords
- Extubation, Laryngeal mask, Craniotomies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu® AuraOnce™ Disposable Laryngeal MaskDevice
Switching endotracheal tube to laryngeal mask at sevoflurane 2.63-2.97%, Removing endotracheal tube when spontaneously generating tidal volume of >4ml/kg, EtCO2<45mmHg, Train of four ratio >70-90%.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia remove endotracheal tube | No intervention | When craniotomy surgery was done, inhalation anesthestic sevoflurane level will control at MAC 2-3%, at the same time we perform suction secretions in endotracheal tube and oral cavity and give neostigmine 0.05-0.07 mg/kg and glycopyrrolate 0.01mg/kg via intravascular catheter. Removing endotracheal tube when spontaneously generating tidal volume of >4ml/kg, EtCO2<45mmHg, Train of four ratio >70-90%. |
| Switching endotracheal tube to laryngeal mask | Experimental | When craniotomy surgery was done, inhalation anesthestic sevoflurane level will control at 2.63%-2.97%, we perform suction secretions in endotracheal tube and oral cavity, then switching endotracheal tube to laryngeal mask. Then we discontinue inhalation anesthestic sevoflurane and support oxygen at the rate of 6L/min. At the same time, give neostigmine 0.05-0.07 mg/kg and glycopyrrolate 0.01mg/kg via intravascular catheter. Removing endotracheal tube when sevofulrane at MAC 0.4, spontaneously generating tidal volume of >4ml/kg, EtCO2<45mmHg, Train of four ratio >70-90%. Receives: Device: Ambu® AuraOnce™ Disposable Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic
Blood pressure including systolic, diastolic and mean arterial pressure and heart rate during extubation
Measured: 30 minutes
Pulmonary complications
Rate of Participants with Cough, Bucking, Laryngospasm, Aspiration, Desaturation(SpO2%< 90%) and Need airway assist device(Nasal or oral airway)
Measured: 24 hours
Partial pressure of carbon dioxide in arterial blood
Partial pressure of carbon dioxide in arterial blood five minutes before and after extubation
Measured: 20 mins
Secondary outcomes (1)
Re-do surgery
Number of Participants with Re-do neurosurgery within 24hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start15 Feb 2022
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Complications, PulmonaryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei. Cheng-Fong, Chang Gung Memorial Hospital
- Investigators
- Yung-Tai Chung, MD, Principal investigator, Chang Gung Memorial HospitalCheng-Fong Wei, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253404
- Sponsor's protocol ID
- 202102115A3
- Status last verified
- Sep 2022
- First submitted
- 8 Feb 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suppiah RK, Rajan S, Paul J, Kumar L. Respiratory and hemodynamic outcomes following exchange extubation with laryngeal mask airway as compared to traditional awake extubation. Anesth Essays Res. 2016 May-Aug;10(2):212-7. doi: 10.4103/0259-1162.174469.
PubMed 27212749Koga K, Asai T, Vaughan RS, Latto IP. Respiratory complications associated with tracheal extubation. Timing of tracheal extubation and use of the laryngeal mask during emergence from anaesthesia. Anaesthesia. 1998 Jun;53(6):540-4. doi: 10.1046/j.1365-2044.1998.00397.x.
PubMed 9709138Wong TH, Weber G, Abramowicz AE. Smooth Extubation and Smooth Emergence Techniques: A Narrative Review. Anesthesiol Res Pract. 2021 Jan 15;2021:8883257. doi: 10.1155/2021/8883257. eCollection 2021.
PubMed 33510786Juang J, Cordoba M, Ciaramella A, Xiao M, Goldfarb J, Bayter JE, Macias AA. Incidence of airway complications associated with deep extubation in adults. BMC Anesthesiol. 2020 Oct 29;20(1):274. doi: 10.1186/s12871-020-01191-8.
PubMed 33121440Wei CF, Chung YT. Laryngeal mask airway facilitates a safe and smooth emergence from anesthesia in patients undergoing craniotomy: a prospective randomized controlled study. BMC Anesthesiol. 2023 Jan 17;23(1):29. doi: 10.1186/s12871-023-01972-x.
PubMed 36650435
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05253404
- Acronym / sponsor ID
- 202102115A3
- Conditions
- Complications, Pulmonary
- Keywords
- Extubation, Laryngeal mask, Craniotomies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- 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.
Stabilizing hemodynamic and reducing pulmonary complications during extubation with switching endotracheal tube to laryngeal mask in craniotomies
Detailed description
recruit ASA: 1-3, 20-65 years old undergoing neurosurgery under general anesthesia Excluded 1.Decline to participated 2.Difficult airway 3.Body Mass Index >30 4. Pregnant woman 5.Nothing Per Os <8hrs(case number:80).
General anesthesia Induction: 0.15-0.2 mg/kg cisatracurium or 0.6-1.2mg rocuronium , 1.5-2 mg/kg propofol, 1-2 mcg/kg Fentanyl. Endotracheal tube 6.5-7.5mm. Maintenance with sevoflurane 2- 3% FiO2:100%. Optimal muscle tension monitor. When surgery done, sevoflurane at 2.63-2.97%
Then randomly assigned two group Anesthesia group(control group) : Removed endotracheal tube at sevoflurane at 2-3% Switching group (intervention group): Intervention with endotracheal tube to laryngeal mask, and removing laryngeal mask at sevoflurane: 0.4MAC
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthesia remove endotracheal tube | No intervention | –When craniotomy surgery was done, inhalation anesthestic sevoflurane level will control at MAC 2-3%, at the same time we perform suction secretions in endotracheal tube and oral cavity and give neostigmine 0.05-0.07 mg/kg and glycopyrrolate 0.01mg/kg via intravascular catheter. Removing endotracheal tube when spontaneously generating tidal volume of >4ml/kg, EtCO2<45mmHg, Train of four ratio >70-90%. |
| Switching endotracheal tube to laryngeal mask | Experimental | Device: Ambu® AuraOnce™ Disposable Laryngeal MaskWhen craniotomy surgery was done, inhalation anesthestic sevoflurane level will control at 2.63%-2.97%, we perform suction secretions in endotracheal tube and oral cavity, then switching endotracheal tube to laryngeal mask. Then we discontinue inhalation anesthestic sevoflurane and support oxygen at the rate of 6L/min. At the same time, give neostigmine 0.05-0.07 mg/kg and glycopyrrolate 0.01mg/kg via intravascular catheter. Removing endotracheal tube when sevofulrane at MAC 0.4, spontaneously generating tidal volume of >4ml/kg, EtCO2<45mmHg, Train of four ratio >70-90%. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA: 1-3, 20-65 years old undergoing craniotomies under general anesthesia
Key exclusion criteria (5 listed)
- Decline to participated
- Difficult airway
- Body Mass Index >30
- Pregnant woman
- Nothing Per Os <8hrs
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 |
|---|---|---|
| Ambu® AuraOnce™ Disposable Laryngeal MaskSwitching endotracheal tube to laryngeal mask at sevoflurane 2.63-2.97%, Removing endotracheal tube when spontaneously generating tidal volume of >4ml/kg, EtCO2<45mmHg, Train of four ratio >70-90%. | Device | Switching endotracheal tube to laryngeal mask |
Primary outcome
Hemodynamic
Time frame: 30 minutes
Blood pressure including systolic, diastolic and mean arterial pressure and heart rate during extubation
Pulmonary complications
Time frame: 24 hours
Rate of Participants with Cough, Bucking, Laryngospasm, Aspiration, Desaturation(SpO2%< 90%) and Need airway assist device(Nasal or oral airway)
Partial pressure of carbon dioxide in arterial blood
Time frame: 20 mins
Partial pressure of carbon dioxide in arterial blood five minutes before and after extubation
1 secondary outcome
Re-do surgery
Time frame: 24 hours
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 14 Sep 2022.
- Background: PubMed 27212749Suppiah RK, Rajan S, Paul J, Kumar L. Respiratory and hemodynamic outcomes following exchange extubation with laryngeal mask airway as compared to traditional awake extubation. Anesth Essays Res. 2016 May-Aug;10(2):212-7. doi: 10.4103/0259-1162.174469.
- Background: PubMed 9709138Koga K, Asai T, Vaughan RS, Latto IP. Respiratory complications associated with tracheal extubation. Timing of tracheal extubation and use of the laryngeal mask during emergence from anaesthesia. Anaesthesia. 1998 Jun;53(6):540-4. doi: 10.1046/j.1365-2044.1998.00397.x.
- Background: PubMed 33510786Wong TH, Weber G, Abramowicz AE. Smooth Extubation and Smooth Emergence Techniques: A Narrative Review. Anesthesiol Res Pract. 2021 Jan 15;2021:8883257. doi: 10.1155/2021/8883257. eCollection 2021.
- Background: PubMed 33121440Juang J, Cordoba M, Ciaramella A, Xiao M, Goldfarb J, Bayter JE, Macias AA. Incidence of airway complications associated with deep extubation in adults. BMC Anesthesiol. 2020 Oct 29;20(1):274. doi: 10.1186/s12871-020-01191-8.
- Derived from this study: PubMed 36650435Wei CF, Chung YT. Laryngeal mask airway facilitates a safe and smooth emergence from anesthesia in patients undergoing craniotomy: a prospective randomized controlled study. BMC Anesthesiol. 2023 Jan 17;23(1):29. doi: 10.1186/s12871-023-01972-x.
- Individual participant dataSharing planned: No
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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.
Yung-Tai Chung, MD principal investigator
Chang Gung Memorial Hospital
Cheng-Fong Wei, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu® AuraOnce™ Disposable Laryngeal Mask in people with Complications, Pulmonary, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 5 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 14 Sep 2022. 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 Taiwan. 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?
Hemodynamic (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05253404, which also lists 5 linked publications.
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 14 Sep 2022.