Airway Complication of AnesthesiaNCT05084612
Comparison Between a Two Person Insertion With Lateral Rotation Technique of LMA and the Classic Technique
A study testing standard LMA insertion and New technique LMA insertion in people with Airway Complication of Anesthesia, run by Benha University at 1 site in Egypt.
Trial summary
The laryngeal Mask Airway was developed by Brain in 1981 and was available for clinical use in the United States by 1992 and has become very popular in routine medicine practice during 10 past years . LMA would serve as a choice to be used in the emergency situations even by the inexperienced users . Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- standard LMA insertion and New technique LMA insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2021to 25 Dec 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status grade I-II,
- Age between 20-55 years old
- undergoing minor surgeries under general anaesthesia using LMA
Who cannot join
- patients at Risk of aspiration,
- Mouth opening ˂ 2.5 cm,
- BMI ≥ 35 kg/m2,
- dental problems,
- recent history of upper airway infection,
- gastro-oesophageal reflux disease and
- limited extension of the neck.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between a Two Person Insertion With Lateral Rotation Technique of Laryngeal Mask Airway and the Classic Technique; a Randomized Controlled Trial
The laryngeal Mask Airway was developed by Brain in 1981 and was available for clinical use in the United States by 1992 and has become very popular in routine medicine practice during 10 past years . LMA would serve as a choice to be used in the emergency situations even by the inexperienced users . Nowadays due to the increasing number of outpatient anesthesia and use of short-acting anesthetics almost without the use of any muscle relaxants requires an appropriate way for safe LMA insertion. As LMA insertion is generally performed blindly, clinicians are always in search of how to place and maintain the LMA in appropriate position.
Read the detailed description
The standard method of insertion described by Dr. Brain is relatively easy, but sometimes it is impossible to insert the LMA with the standard method. However ease and time of airway management may be of special importance in emergent situations. Since its inception the LMA has undergone various modifications in type and material, which have made other methods of insertion possible, quicker and easier than the standard method. Intraoral manipulation can put the operator at risk of finger trauma and infection. However it is not possible to avoid intraoral manipulation when the standard technique or the classic LMA is used.
Therefore, many studies were seeking to find new methods to improve this technique. Hwang et al. first described The 90° rotation technique in adults that involves the following steps: the entire cuff of the LMA is inserted inside the mouth, rotated counter-clockwise through 90° and advanced until the resistance of the hypopharynx is felt . The use of this method is known to increase the success rate of insertion and decrease the incidence of blood staining of the LMA and sore throat compared to standard technique . Ghai et al. showed that rotational technique may be considered as the first technique of choice for classical laryngeal mask airway insertion in children . Lopez-Gil and colleagues reported a decrease in complications with the increase in the skill of the anaesthetist . PARVIZ et al. described a two person technique which performed by the technician who performs mouth opening and jaw thrust and the anesthesiologist who inserts the laryngeal mask. They considered it as a safe and effective method to establish a secure airway in anesthetized patients.. other studies have shown that LMA insertion with partially inflated cuff is easier than deflated cuff .
Current study will combine two methods of LMA insertion including two-persons and lateral rotational techniques and compare them with the standard insertion method regarding the success rate and incidence of complications.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- standard LMA insertion, New technique LMA insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard LMA insertionDevice
Following pre-oxygenation, anaesthesia will be induced with atropine 0.1mg/kg, Fentanyl 2 µg /kg, Propofol 2 mg/kg and atracurium 0.5 mg/kg. When neuromuscular blockade will be complete
the laryngeal mask will be inserted with using the standard method described by Brain; after lubrication of the posterior aspect of the partially deflated mask, the patient's head will be positioned with head extended at the atlanto-axial joint and flexed at the neck with non-dominant hand. The LMA will be held like a pen and index finger will be placed at the junction of LMA tube and cuff. Index finger will be used to press the LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of the hypopharynx. LMA will then be held with non-dominant hand and index finger will be removed.
New technique LMA insertionDevice
Following pre-oxygenation, anaesthesia will be induced with atropine 0.1mg/kg, Fentanyl 2 µg /kg, Propofol 2 mg/kg and atracurium 0.5 mg/kg. When neuromuscular blockade will be complete LMA will be inserted by a two Person Insertion with lateral rotation Technique; after lubrication of the posterior aspect of the partially deflated mask, the assistant will achieve jaw thrust and mouth opening then LMA will be inserted by the anaesthiologist. LMA will be inserted by holding the mask by index, middle finger and thumb; after insertion of the entire cuff inside the mouth, the LMA will be rotated anticlockwise through 90° (the inner surface of LMA will be directed medially towards the mouth cavity) and advanced through the side of the tongue until resistance felt, then turned back in the hypopharynx.
| Study group | Role | What they receive |
|---|---|---|
| control group (S) | Placebo comparator | LMA will be placed using the standard Brain's insertion technique. Receives: Device: standard LMA insertion |
| Rotational group (R) | Active comparator | LMA will be placed using a two Person Insertion with lateral rotation technique. Receives: Device: New technique LMA insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate of first attempt insertion of the LMA
confirmed insertion of LMA without need for further attempts.
Measured: from induction of anesthesia till patient connected to the ventilator.
Secondary outcomes (5)
LMA insertion time
the period from mouth passage of the device to effective ventilation after inflation of the cuff.
Measured: up to 30 minutes post-induction of anesthesia
The number of insertion attempts
If ventilation is still ineffective, re-insertion will be tried up to three times. After third unsuccessful attempt then one attempt will be made using the alternative approach, if still unsuccessful endotracheal tube will be inserted.
Measured: up to 30 minutes post-induction of anesthesia
number of manipulations needed during insertion
manipulations like jaw thrust, chin lift, and extension and flexion of the neck
Measured: up to 30 minutes post-induction of anesthesia
The incidence of complications following insertion of LMA
including; laryngospasm, hypoxaemia (SpO2 < 90%) and trauma (assessed by blood stained LMA on removal)
Measured: up to 1 day postoperative
Heart rate (HR)
monitoring of stress response during the maneuver
Measured: first 15 minutes post-induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start2 Aug 2021
- Primary completion20 Nov 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Why it stopped: The 107 the principal investigator was changed on November, 2022.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084612
- Sponsor's protocol ID
- RC4-4-2021
- Status last verified
- Aug 2024
- First submitted
- 27 Sep 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a Two Person Insertion With Lateral Rotation Technique of Laryngeal Mask Airway and the Classic Technique; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05084612
- Acronym / sponsor ID
- RC4-4-2021
- Conditions
- Airway Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The 107 the principal investigator was changed on November, 2022.
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 20 Oct 2021 (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.
The laryngeal Mask Airway was developed by Brain in 1981 and was available for clinical use in the United States by 1992 and has become very popular in routine medicine practice during 10 past years . LMA would serve as a choice to be used in the emergency situations even by the inexperienced users . Nowadays due to the increasing number of outpatient anesthesia and use of short-acting anesthetics almost without the use of any muscle relaxants requires an appropriate way for safe LMA insertion. As LMA insertion is generally performed blindly, clinicians are always in search of how to place and maintain the LMA in appropriate position.
Detailed description
The standard method of insertion described by Dr. Brain is relatively easy, but sometimes it is impossible to insert the LMA with the standard method. However ease and time of airway management may be of special importance in emergent situations. Since its inception the LMA has undergone various modifications in type and material, which have made other methods of insertion possible, quicker and easier than the standard method. Intraoral manipulation can put the operator at risk of finger trauma and infection. However it is not possible to avoid intraoral manipulation when the standard technique or the classic LMA is used.
Therefore, many studies were seeking to find new methods to improve this technique. Hwang et al. first described The 90° rotation technique in adults that involves the following steps: the entire cuff of the LMA is inserted inside the mouth, rotated counter-clockwise through 90° and advanced until the resistance of the hypopharynx is felt . The use of this method is known to increase the success rate of insertion and decrease the incidence of blood staining of the LMA and sore throat compared to standard technique . Ghai et al. showed that rotational technique may be considered as the first technique of choice for classical laryngeal mask airway insertion in children . Lopez-Gil and colleagues reported a decrease in complications with the increase in the skill of the anaesthetist . PARVIZ et al. described a two person technique which performed by the technician who performs mouth opening and jaw thrust and the anesthesiologist who inserts the laryngeal mask. They considered it as a safe and effective method to establish a secure airway in anesthetized patients.. other studies have shown that LMA insertion with partially inflated cuff is easier than deflated cuff .
Current study will combine two methods of LMA insertion including two-persons and lateral rotational techniques and compare them with the standard insertion method regarding the success rate and incidence of complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group (S) | Placebo comparator | Device: standard LMA insertionLMA will be placed using the standard Brain's insertion technique. |
| Rotational group (R) | Active comparator | Device: New technique LMA insertionLMA will be placed using a two Person Insertion with lateral rotation technique. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status grade I-II,
- Age between 20-55 years old
- undergoing minor surgeries under general anaesthesia using LMA
Key exclusion criteria (7 listed)
- patients at Risk of aspiration,
- Mouth opening ˂ 2.5 cm,
- BMI ≥ 35 kg/m2,
- dental problems,
- recent history of upper airway infection,
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 |
|---|---|---|
| standard LMA insertionFollowing pre-oxygenation, anaesthesia will be induced with atropine 0.1mg/kg, Fentanyl 2 µg /kg, Propofol 2 mg/kg and atracurium 0.5 mg/kg. When neuromuscular blockade will be complete the laryngeal mask will be inserted with using the standard method described by Brain; after lubrication of the posterior aspect of the partially deflated mask, the patient's head will be positioned with head extended at the atlanto-axial joint and flexed at the neck with non-dominant hand. The LMA will be held like a pen and index finger will be placed at the junction of LMA tube and cuff. Index finger will be used to press the LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of the hypopharynx. LMA will then be held with non-dominant hand and index finger will be removed. | Device | control group (S) |
| New technique LMA insertionFollowing pre-oxygenation, anaesthesia will be induced with atropine 0.1mg/kg, Fentanyl 2 µg /kg, Propofol 2 mg/kg and atracurium 0.5 mg/kg. When neuromuscular blockade will be complete LMA will be inserted by a two Person Insertion with lateral rotation Technique; after lubrication of the posterior aspect of the partially deflated mask, the assistant will achieve jaw thrust and mouth opening then LMA will be inserted by the anaesthiologist. LMA will be inserted by holding the mask by index, middle finger and thumb; after insertion of the entire cuff inside the mouth, the LMA will be rotated anticlockwise through 90° (the inner surface of LMA will be directed medially towards the mouth cavity) and advanced through the side of the tongue until resistance felt, then turned back in the hypopharynx. | Device | Rotational group (R) |
Primary outcome
the success rate of first attempt insertion of the LMA
Time frame: from induction of anesthesia till patient connected to the ventilator.
confirmed insertion of LMA without need for further attempts.
5 secondary outcomes
LMA insertion time
Time frame: up to 30 minutes post-induction of anesthesia
The number of insertion attempts
Time frame: up to 30 minutes post-induction of anesthesia
number of manipulations needed during insertion
Time frame: up to 30 minutes post-induction of anesthesia
The incidence of complications following insertion of LMA
Time frame: up to 1 day postoperative
Heart rate (HR)
Time frame: first 15 minutes post-induction of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard LMA insertion and New technique LMA insertion in people with Airway Complication of Anesthesia, run by Benha University at 1 site in Egypt.
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 3 inclusion and 7 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: paused, as of the sponsor's last update on 15 Aug 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
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?
the success rate of first attempt insertion of the LMA (time frame: from induction of anesthesia till patient connected to the ventilator.). 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 15 Aug 2024.