Spontaneous BreathingNCT05420649
Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia
A study testing Non-intubated Laryngomicrosurgery in people with Spontaneous Breathing and Laryngomicrosurgery, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Nonintubated anesthesia applied in combination with high-flow nasal oxygen (HFNO) is an alternative strategy for laryngeal microsurgery (LMS). LMS is a common procedure in otolaryngology that typically requires endotracheal tube intubation under general anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spontaneous Breathing, Laryngomicrosurgery, Superior Laryngeal Nerve Block
- What is being tested?
- Non-intubated Laryngomicrosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Oct 2020to 26 Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient who needed to undergo LMS.
Who cannot join
- Severe airway obstruction.
- Severe airway disease.
- American Society of anesthesiologists (ASA) physical state > III.
- Pregnancy or body mass index (BMI) ≥ 40 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia With Combination of Superior Laryngeal Nerve Block
Nonintubated anesthesia applied in combination with high-flow nasal oxygen (HFNO) is an alternative strategy for laryngeal microsurgery (LMS). LMS is a common procedure in otolaryngology that typically requires endotracheal tube intubation under general anesthesia. Endotracheal tube intubation causes complications; a nonintubated strategy can avoid these complications and provide a clearer surgical field of vision, enabling vocal cord inspection and disposal. Administering a muscle relaxant can also help prevent bucking during surgery but can engender apnea and hypercapnia, which may have negative effects on hemodynamics. Therefore, the investigators assessed the effectiveness of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia in maintaining spontaneous breathing and improving safety during LMS with nonintubated anesthesia.
Read the detailed description
Laryngeal microsurgery (LMS) is among the most common operations in otolaryngology and typically requires general anesthesia administered through endotracheal tube intubation. Endotracheal tube intubation provides stable gas exchange, protects the airways by preventing secretions from falling into the lower respiratory tract, and enables the monitoring of parameters such as tidal volume and end-tidal CO2.
Nonintubated anesthesia applied in combination with transnasal humidified rapid-insufflation ventilatory exchange or high-flow nasal oxygen (HFNO) is another option for LMS. LMS with nonintubated anesthesia can avoid the complications caused by endotracheal tube intubation such as oral tissue trauma, tracheal trauma, and dental injury. Furthermore, LMS with nonintubated anesthesia can provide a clearer surgical field of vision that allows the vocal cords to be inspected and disposed of completely. Current practice in LMS with nonintubated anesthesia is to administer a muscle relaxant to help avoid bucking during the procedure. However, the administration of a muscle relaxant can lead to apnea and hypercapnia, which may negatively affect hemodynamics. Therefore, the investigators investigated the use of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia to help the patient maintain spontaneous breathing and provide higher surgical safety during LMS with nonintubated anesthesia.
- Being tested
- Non-intubated Laryngomicrosurgery
- Keywords
- Nonintubated, Spontaneous breathing, Laryngomicrosurgery, Superior laryngeal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intubated LaryngomicrosurgeryProcedure or surgery
Non-intubated LMS was performed with assistance of Optiflow (HFNO).
| Study group | Role | What they receive |
|---|---|---|
| Intubated general anesthesia LMS | No intervention | Patients received LMS with intubated general anesthesia |
| Non-intubated LMS with apnea | Experimental | Patients received non-intubated LMS with administration of muscle relaxant and optiflow(HFNO) device. Receives: Procedure: Non-intubated Laryngomicrosurgery |
| Non-intubated LMS with spontaneous breathing | Experimental | Patients received non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing. Receives: Procedure: Non-intubated Laryngomicrosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaCO2 after Laryngomicrosurgery
ABG was measured immediately after the end of LMS
Measured: ABG was measured immediately after the end of LMS
Secondary outcomes (2)
pH after Laryngomicrosurgery
ABG was measured immediately after the end of LMS
Measured: ABG was measured immediately after the end of LMS
Heart rate (HR)
Hemodynamic data were measured every 5 minutes
Measured: during the LMS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start20 Oct 2020
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Spontaneous BreathingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Yi Chia, Kaohsiung Veterans General Hospital.
- Investigators
- Yuan Yi Chia, Director, Principal investigator, Kaohsiung Veterans General Hospital.Yu Ting Kuo, physician, Study director, Kaohsiung Veterans General Hospital.Ting Shou Chang, physician, Study director, Kaohsiung Veterans General Hospital.Chih Chi Tsai, RA, Study chair, Kaohsiung Veterans General Hospital.Li-Ya Tseng, physician, Study director, Kaohsiung Veterans General Hospital.Pei-Wen Shen, physician, Study director, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420649
- Sponsor's protocol ID
- KSVGH20-CT9-09
- Status last verified
- Oct 2023
- First submitted
- 3 May 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Booth AWG, Vidhani K, Lee PK, Thomsett CM. SponTaneous Respiration using IntraVEnous anaesthesia and Hi-flow nasal oxygen (STRIVE Hi) maintains oxygenation and airway patency during management of the obstructed airway: an observational study. Br J Anaesth. 2017 Mar 1;118(3):444-451. doi: 10.1093/bja/aew468.
PubMed 28203745Montgomery J, Melia L, O'Donnell N, MacKenzie K. Intubation trauma and the head and neck surgeon: issues with a shared airway. J R Soc Med. 2015 Nov;108(11):426-8. doi: 10.1177/0141076815614803. No abstract available.
PubMed 26609095Yang SH, Wu CY, Tseng WH, Cherng WY, Hsiao TY, Cheng YJ, Chan KC. Nonintubated laryngomicrosurgery with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange: A case series. J Formos Med Assoc. 2019 Jul;118(7):1138-1143. doi: 10.1016/j.jfma.2018.11.009. Epub 2018 Dec 3.
PubMed 30522856Catalano G, Robeel RA, Cheney GA, Spurling BC, Catalano MC, Schultz SK, Sanchez DL. Antidepressant Augmentation: A Review of the Literature and a Review of the Pharmacoeconomic Considerations. J Clin Psychopharmacol. 2020 Jul/Aug;40(4):396-400. doi: 10.1097/JCP.0000000000001236.
PubMed 32639292Yasar NF, Uylas MU, Badak B, Bilge U, Oner S, Ihtiyar E, Caga T, Pasaoglu E. Can we predict mortality in patients with necrotizing fasciitis using conventional scoring systems? Ulus Travma Acil Cerrahi Derg. 2017 Sep;23(5):383-388. doi: 10.5505/tjtes.2016.19940.
PubMed 29052823Booth AWG, Vidhani K, Lee PK, Coman SH, Pelecanos AM, Dimeski G, Sturgess DJ. The Effect of High-Flow Nasal Oxygen on Carbon Dioxide Accumulation in Apneic or Spontaneously Breathing Adults During Airway Surgery: A Randomized-Controlled Trial. Anesth Analg. 2021 Jul 1;133(1):133-141. doi: 10.1213/ANE.0000000000005002.
PubMed 32618626Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.
PubMed 26329355Williams R, Rankin N, Smith T, Galler D, Seakins P. Relationship between the humidity and temperature of inspired gas and the function of the airway mucosa. Crit Care Med. 1996 Nov;24(11):1920-9. doi: 10.1097/00003246-199611000-00025.
PubMed 8917046Bernards CM, Knowlton SL, Schmidt DF, DePaso WJ, Lee MK, McDonald SB, Bains OS. Respiratory and sleep effects of remifentanil in volunteers with moderate obstructive sleep apnea. Anesthesiology. 2009 Jan;110(1):41-9. doi: 10.1097/ALN.0b013e318190b501.
PubMed 19104169Stockwell M, Lozanoff S, Lang SA, Nyssen J. Superior laryngeal nerve block: an anatomical study. Clin Anat. 1995;8(2):89-95. doi: 10.1002/ca.980080202.
PubMed 7712327Manikandan S, Neema PK, Rathod RC. Ultrasound-guided bilateral superior laryngeal nerve block to aid awake endotracheal intubation in a patient with cervical spine disease for emergency surgery. Anaesth Intensive Care. 2010 Sep;38(5):946-8. doi: 10.1177/0310057X1003800523.
PubMed 20865885Pani N, Kumar Rath S. Regional & topical anaesthesia of upper airways. Indian J Anaesth. 2009 Dec;53(6):641-8.
PubMed 20640090Menda F, Koner O, Sayin M, Ture H, Imer P, Aykac B. Dexmedetomidine as an adjunct to anesthetic induction to attenuate hemodynamic response to endotracheal intubation in patients undergoing fast-track CABG. Ann Card Anaesth. 2010 Jan-Apr;13(1):16-21. doi: 10.4103/0971-9784.58829.
PubMed 20075530Chopra P, Dixit MB, Dang A, Gupta V. Dexmedetomidine provides optimum conditions during awake fiberoptic intubation in simulated cervical spine injury patients. J Anaesthesiol Clin Pharmacol. 2016 Jan-Mar;32(1):54-8. doi: 10.4103/0970-9185.175666.
PubMed 27006542Michard F. Changes in arterial pressure during mechanical ventilation. Anesthesiology. 2005 Aug;103(2):419-28; quiz 449-5. doi: 10.1097/00000542-200508000-00026.
PubMed 16052125
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia With Combination of Superior Laryngeal Nerve Block
- ClinicalTrials.gov ID
- NCT05420649
- Acronym / sponsor ID
- KSVGH20-CT9-09
- Keywords
- Nonintubated, Spontaneous breathing, Laryngomicrosurgery, Superior laryngeal nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 15 Jun 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.
Nonintubated anesthesia applied in combination with high-flow nasal oxygen (HFNO) is an alternative strategy for laryngeal microsurgery (LMS). LMS is a common procedure in otolaryngology that typically requires endotracheal tube intubation under general anesthesia. Endotracheal tube intubation causes complications; a nonintubated strategy can avoid these complications and provide a clearer surgical field of vision, enabling vocal cord inspection and disposal. Administering a muscle relaxant can also help prevent bucking during surgery but can engender apnea and hypercapnia, which may have negative effects on hemodynamics. Therefore, the investigators assessed the effectiveness of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia in maintaining spontaneous breathing and improving safety during LMS with nonintubated anesthesia.
Detailed description
Laryngeal microsurgery (LMS) is among the most common operations in otolaryngology and typically requires general anesthesia administered through endotracheal tube intubation. Endotracheal tube intubation provides stable gas exchange, protects the airways by preventing secretions from falling into the lower respiratory tract, and enables the monitoring of parameters such as tidal volume and end-tidal CO2.
Nonintubated anesthesia applied in combination with transnasal humidified rapid-insufflation ventilatory exchange or high-flow nasal oxygen (HFNO) is another option for LMS. LMS with nonintubated anesthesia can avoid the complications caused by endotracheal tube intubation such as oral tissue trauma, tracheal trauma, and dental injury. Furthermore, LMS with nonintubated anesthesia can provide a clearer surgical field of vision that allows the vocal cords to be inspected and disposed of completely. Current practice in LMS with nonintubated anesthesia is to administer a muscle relaxant to help avoid bucking during the procedure. However, the administration of a muscle relaxant can lead to apnea and hypercapnia, which may negatively affect hemodynamics. Therefore, the investigators investigated the use of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia to help the patient maintain spontaneous breathing and provide higher surgical safety during LMS with nonintubated anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intubated general anesthesia LMS | No intervention | –Patients received LMS with intubated general anesthesia |
| Non-intubated LMS with apnea | Experimental | Procedure: Non-intubated LaryngomicrosurgeryPatients received non-intubated LMS with administration of muscle relaxant and optiflow(HFNO) device. |
| Non-intubated LMS with spontaneous breathing | Experimental | Procedure: Non-intubated LaryngomicrosurgeryPatients received non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patient who needed to undergo LMS.
Key exclusion criteria (4 listed)
- Severe airway obstruction.
- Severe airway disease.
- American Society of anesthesiologists (ASA) physical state > III.
- Pregnancy or body mass index (BMI) ≥ 40 kg/m2.
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 |
|---|---|---|
| Non-intubated LaryngomicrosurgeryNon-intubated LMS was performed with assistance of Optiflow (HFNO). | Procedure or surgery | Non-intubated LMS with apnea, Non-intubated LMS with spontaneous breathing |
Primary outcome
PaCO2 after Laryngomicrosurgery
Time frame: ABG was measured immediately after the end of LMS
ABG was measured immediately after the end of LMS
2 secondary outcomes
pH after Laryngomicrosurgery
Time frame: ABG was measured immediately after the end of LMS
Heart rate (HR)
Time frame: during the LMS procedure
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 27 Oct 2023.
- Background: PubMed 28203745Booth AWG, Vidhani K, Lee PK, Thomsett CM. SponTaneous Respiration using IntraVEnous anaesthesia and Hi-flow nasal oxygen (STRIVE Hi) maintains oxygenation and airway patency during management of the obstructed airway: an observational study. Br J Anaesth. 2017 Mar 1;118(3):444-451. doi: 10.1093/bja/aew468.
- Background: PubMed 26609095Montgomery J, Melia L, O'Donnell N, MacKenzie K. Intubation trauma and the head and neck surgeon: issues with a shared airway. J R Soc Med. 2015 Nov;108(11):426-8. doi: 10.1177/0141076815614803. No abstract available.
- Background: PubMed 30522856Yang SH, Wu CY, Tseng WH, Cherng WY, Hsiao TY, Cheng YJ, Chan KC. Nonintubated laryngomicrosurgery with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange: A case series. J Formos Med Assoc. 2019 Jul;118(7):1138-1143. doi: 10.1016/j.jfma.2018.11.009. Epub 2018 Dec 3.
- Background: PubMed 32639292Catalano G, Robeel RA, Cheney GA, Spurling BC, Catalano MC, Schultz SK, Sanchez DL. Antidepressant Augmentation: A Review of the Literature and a Review of the Pharmacoeconomic Considerations. J Clin Psychopharmacol. 2020 Jul/Aug;40(4):396-400. doi: 10.1097/JCP.0000000000001236.
- Background: PubMed 29052823Yasar NF, Uylas MU, Badak B, Bilge U, Oner S, Ihtiyar E, Caga T, Pasaoglu E. Can we predict mortality in patients with necrotizing fasciitis using conventional scoring systems? Ulus Travma Acil Cerrahi Derg. 2017 Sep;23(5):383-388. doi: 10.5505/tjtes.2016.19940.
- Background: PubMed 32618626Booth AWG, Vidhani K, Lee PK, Coman SH, Pelecanos AM, Dimeski G, Sturgess DJ. The Effect of High-Flow Nasal Oxygen on Carbon Dioxide Accumulation in Apneic or Spontaneously Breathing Adults During Airway Surgery: A Randomized-Controlled Trial. Anesth Analg. 2021 Jul 1;133(1):133-141. doi: 10.1213/ANE.0000000000005002.
- Background: PubMed 26329355Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.
- Background: PubMed 8917046Williams R, Rankin N, Smith T, Galler D, Seakins P. Relationship between the humidity and temperature of inspired gas and the function of the airway mucosa. Crit Care Med. 1996 Nov;24(11):1920-9. doi: 10.1097/00003246-199611000-00025.
- Background: PubMed 19104169Bernards CM, Knowlton SL, Schmidt DF, DePaso WJ, Lee MK, McDonald SB, Bains OS. Respiratory and sleep effects of remifentanil in volunteers with moderate obstructive sleep apnea. Anesthesiology. 2009 Jan;110(1):41-9. doi: 10.1097/ALN.0b013e318190b501.
- Background: PubMed 7712327Stockwell M, Lozanoff S, Lang SA, Nyssen J. Superior laryngeal nerve block: an anatomical study. Clin Anat. 1995;8(2):89-95. doi: 10.1002/ca.980080202.
- Background: PubMed 20865885Manikandan S, Neema PK, Rathod RC. Ultrasound-guided bilateral superior laryngeal nerve block to aid awake endotracheal intubation in a patient with cervical spine disease for emergency surgery. Anaesth Intensive Care. 2010 Sep;38(5):946-8. doi: 10.1177/0310057X1003800523.
- Background: PubMed 20640090Pani N, Kumar Rath S. Regional & topical anaesthesia of upper airways. Indian J Anaesth. 2009 Dec;53(6):641-8.
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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.
Yuan Yi Chia, Director principal investigator
Kaohsiung Veterans General Hospital.
Yu Ting Kuo, physician study director
Kaohsiung Veterans General Hospital.
Ting Shou Chang, physician study director
Kaohsiung Veterans General 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 Non-intubated Laryngomicrosurgery in people with Spontaneous Breathing and Laryngomicrosurgery, run by Kaohsiung Veterans General 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 4 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 27 Oct 2023. 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?
PaCO2 after Laryngomicrosurgery (time frame: ABG was measured immediately after the end of LMS). 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 NCT05420649, which also lists 21 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 27 Oct 2023.