Clinical trial NCT05084612: Comparison Between a Two Person Insertion With Lateral Rotation Technique of LMA and the Classic Technique
Official title: Comparison Between a Two Person Insertion With Lateral Rotation Technique of Laryngeal Mask Airway and the Classic Technique; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Airway Complication of Anesthesia
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 . 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.

Eligibility criteria: Inclusion Criteria:

* ASA physical status grade I-II,
* Age between 20-55 years old
* undergoing minor surgeries under general anaesthesia using LMA

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the success rate of first attempt insertion of the LMA
timeFrame: from induction of anesthesia till patient connected to the ventilator.
Secondary outcomes:
measure: LMA insertion time
timeFrame: up to 30 minutes post-induction of anesthesia
measure: The number of insertion attempts
timeFrame: up to 30 minutes post-induction of anesthesia
measure: number of manipulations needed during insertion
timeFrame: up to 30 minutes post-induction of anesthesia
measure: The incidence of complications following insertion of LMA
timeFrame: up to 1 day postoperative
measure: Heart rate (HR)
timeFrame: first 15 minutes post-induction of anesthesia
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Samar Rafik Amin
state: Qalubia
Study officials:
References: