Comparison of Different Laryngeal Mask Wearing MethodsNCT04509960
Different Ways of Airway Management in Elective Minor Surgeries in Geriatric Patients
A study testing direct laryngoskopy in people with Comparison of Different Laryngeal Mask Wearing Methods, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
different ways of airway management in elective minor surgeries of geriatric patients Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Comparison of Different Laryngeal Mask Wearing Methods
- What is being tested?
- direct laryngoskopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 30 Apr 2021
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I or II or III
- Who were scheduled to minor elective ambulatory surgery (e.g. urology operations)
- Patients undergoing general anesthesia
- Those who are planned to wear a laryngeal mask for surgical procedure
Who cannot join
- patients with full stomach
- A history of gastric reflux
- A history of convulsions, cardiovascular or neuromuscular disease
- Allergies to the study drugs
- obese (Body mass index (BMI) ≥ 40 kg / m2)
- suspected difficult airway and hyper-reactive airway disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Siences Diskapi Yildirim Beyazit T&R hospital
Ankara
About this study
Official title: Comparison of Airway Placement Conditions and Postoperative Effects of Laryngoscope-guided Laryngeal Mask Placement Methods in Sniffing Position in Geriatric Edentulous Patients
different ways of airway management in elective minor surgeries of geriatric patients
Read the detailed description
The investigators will used two different ways of pro-seal laryngeal mask insertion technique (laryngoscopy- guided technique or the standard technique) in elective minor surgeries of geriatric toothless patients.
The investigators will record the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. The investigators will record the laryngeal mask insertion time and oropharyngeal leakage pressure. The investigators will evaluate the placement of a laryngeal mask according to young criteria. The development and severity of coughing, retching, laryngospasm, extremity, and head movement during laryngeal mask placement will be recorded. Bloodstains, sore throat, hoarseness will be recorded on the mask that may develop due to laryngeal mask placement. The investigators will use the Briacombe scoring and Campbell category system to assess the position of laryngeal mask airway devices.
- Being tested
- direct laryngoskopy
- Keywords
- laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct laryngoskopyDevice
Proseal Laryngeal mask inserted with direct laryngoskopy
| Study group | Role | What they receive |
|---|---|---|
| proseal laryngeal mask insertion | No intervention | no intervention |
| proseal laryngeal mask insertion with laryngoscope | Experimental | with the help of direct laryngoscopy Receives: Device: direct laryngoskopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
laryngeal mask placement
To evaluate the best fiberoptic bronchoscopic view while insertion of pro-Seal laryngeal mask either in a classic way, or with the help of laryngoscope. The fibreoptic evaluation Includes 4, only vocal cords visible; 3, vocal cords plus posterior epiglottis visible 2, vocal cords plus anterior epiglottis visible
; 1, vocal cords not seen.
Measured: First minute after laryngeal mask insertio
complications of laryngeal mask insertion
complications like sore throat, hoarseness, nausea, and vomiting or Bloodstain on the laryngeal mask.
we simply asked patients about them
Measured: Complications will be evaluated within 1 hour after patient recovery.
Secondary outcomes (7)
hemodynamic response
Heart rate will record before LMA and post LMA used at first minute
Measured: Before putting on the Layngeal mask, it will record in beats / minute at 5 minutes for 1 minute and 20 minutes after wearing
insertion time
Insertion time was defined from the time of removal of the facemask to the time of the appearance of first capnography upstroke. we assessed this outcome stopwatch
Measured: The investigator will record the insertion time in seconds from the moment the laryngeal mask airway passes the incisors until the end-tidal CO2 is visible.
respiratory dynamics
The investigator will record the (tidal volume(ml) value from the mechanical ventilator after wearing the laryngeal mask.
Measured: The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
hemodynamic responce
mean blood pressure will record before LMA and post LMA used at first minute
Measured: Before putting on the Layngeal mask, it will record in mm Hg at 5 minutes for 1 minute and 20 minutes after wearing
oxygen saturation
saturation will record before LMA and post LMA used at first minute
Measured: Before putting on the Layngeal mask, it will record in %SpO2 at 5 minutes for 1 minute and 20 minutes after wearing
respiratory dynamics
The investigator will record the peak airway pressure (cmH2O) value from the mechanical ventilator after wearing the laryngeal mask.
Measured: The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
respiratory dynamics
The investigator will record the end-tidal CO2(mmHg) value from the mechanical ventilator after wearing the laryngeal mask.
Measured: The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start15 Jan 2021 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Comparison of Different Laryngeal Mask Wearing MethodsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Akaslan, Ankara Diskapi Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509960
- Sponsor's protocol ID
- LMA
- Status last verified
- Jan 2021
- First submitted
- 13 Jun 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chandan SN, Sharma SM, Raveendra US, Rajendra Prasad B. Fiberoptic assessment of laryngeal mask airway placement: a comparison of blind insertion and insertion with the use of a laryngoscope. J Maxillofac Oral Surg. 2009 Jun;8(2):95-8. doi: 10.1007/s12663-009-0025-8. Epub 2009 Aug 11.
PubMed 23139483Kim GW, Kim JY, Kim SJ, Moon YR, Park EJ, Park SY. Conditions for laryngeal mask airway placement in terms of oropharyngeal leak pressure: a comparison between blind insertion and laryngoscope-guided insertion. BMC Anesthesiol. 2019 Jan 5;19(1):4. doi: 10.1186/s12871-018-0674-6.
PubMed 30611202Choo CY, Koay CK, Yoong CS. A randomised controlled trial comparing two insertion techniques for the Laryngeal Mask Airway Flexible in patients undergoing dental surgery. Anaesthesia. 2012 Sep;67(9):986-90. doi: 10.1111/j.1365-2044.2012.07167.x. Epub 2012 Jun 11.
PubMed 22686571
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Airway Placement Conditions and Postoperative Effects of Laryngoscope-guided Laryngeal Mask Placement Methods in Sniffing Position in Geriatric Edentulous Patients
- ClinicalTrials.gov ID
- NCT04509960
- Acronym / sponsor ID
- LMA
- Keywords
- laryngeal mask
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 12 Aug 2020 (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.
different ways of airway management in elective minor surgeries of geriatric patients
Detailed description
The investigators will used two different ways of pro-seal laryngeal mask insertion technique (laryngoscopy- guided technique or the standard technique) in elective minor surgeries of geriatric toothless patients.
The investigators will record the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. The investigators will record the laryngeal mask insertion time and oropharyngeal leakage pressure. The investigators will evaluate the placement of a laryngeal mask according to young criteria. The development and severity of coughing, retching, laryngospasm, extremity, and head movement during laryngeal mask placement will be recorded. Bloodstains, sore throat, hoarseness will be recorded on the mask that may develop due to laryngeal mask placement. The investigators will use the Briacombe scoring and Campbell category system to assess the position of laryngeal mask airway devices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proseal laryngeal mask insertion | No intervention | –no intervention |
| proseal laryngeal mask insertion with laryngoscope | Experimental | Device: direct laryngoskopywith the help of direct laryngoscopy |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status I or II or III
- Who were scheduled to minor elective ambulatory surgery (e.g. urology operations)
- Patients undergoing general anesthesia
- Those who are planned to wear a laryngeal mask for surgical procedure
Key exclusion criteria (6 listed)
- patients with full stomach
- A history of gastric reflux
- A history of convulsions, cardiovascular or neuromuscular disease
- Allergies to the study drugs
- obese (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 |
|---|---|---|
| direct laryngoskopyProseal Laryngeal mask inserted with direct laryngoskopy | Device | proseal laryngeal mask insertion with laryngoscope |
Primary outcome
laryngeal mask placement
Time frame: First minute after laryngeal mask insertio
To evaluate the best fiberoptic bronchoscopic view while insertion of pro-Seal laryngeal mask either in a classic way, or with the help of laryngoscope. The fibreoptic evaluation Includes 4, only vocal cords visible; 3, vocal cords plus posterior epiglottis visible 2, vocal cords plus anterior epiglottis visible ; 1, vocal cords not seen.
complications of laryngeal mask insertion
Time frame: Complications will be evaluated within 1 hour after patient recovery.
complications like sore throat, hoarseness, nausea, and vomiting or Bloodstain on the laryngeal mask. we simply asked patients about them
7 secondary outcomes
hemodynamic response
Time frame: Before putting on the Layngeal mask, it will record in beats / minute at 5 minutes for 1 minute and 20 minutes after wearing
insertion time
Time frame: The investigator will record the insertion time in seconds from the moment the laryngeal mask airway passes the incisors until the end-tidal CO2 is visible.
respiratory dynamics
Time frame: The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
hemodynamic responce
Time frame: Before putting on the Layngeal mask, it will record in mm Hg at 5 minutes for 1 minute and 20 minutes after wearing
oxygen saturation
Time frame: Before putting on the Layngeal mask, it will record in %SpO2 at 5 minutes for 1 minute and 20 minutes after wearing
respiratory dynamics
Time frame: The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
respiratory dynamics
Time frame: The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 23139483Chandan SN, Sharma SM, Raveendra US, Rajendra Prasad B. Fiberoptic assessment of laryngeal mask airway placement: a comparison of blind insertion and insertion with the use of a laryngoscope. J Maxillofac Oral Surg. 2009 Jun;8(2):95-8. doi: 10.1007/s12663-009-0025-8. Epub 2009 Aug 11.
- Background: PubMed 30611202Kim GW, Kim JY, Kim SJ, Moon YR, Park EJ, Park SY. Conditions for laryngeal mask airway placement in terms of oropharyngeal leak pressure: a comparison between blind insertion and laryngoscope-guided insertion. BMC Anesthesiol. 2019 Jan 5;19(1):4. doi: 10.1186/s12871-018-0674-6.
- Background: PubMed 22686571Choo CY, Koay CK, Yoong CS. A randomised controlled trial comparing two insertion techniques for the Laryngeal Mask Airway Flexible in patients undergoing dental surgery. Anaesthesia. 2012 Sep;67(9):986-90. doi: 10.1111/j.1365-2044.2012.07167.x. Epub 2012 Jun 11.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct laryngoskopy in people with Comparison of Different Laryngeal Mask Wearing Methods, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filiz Akaslan (03125962553, flz_karaca@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laryngeal mask placement (time frame: First minute after laryngeal mask insertio). The study lists 2 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 NCT04509960, which also lists 3 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 5 Jan 2021.