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Comparison Between the I-gel and the LMA-Unique

The Influence of Head and Neck Position On The Oropharyngeal Leak Pressure of LMA Unique ™ and I-GEL™

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02163486
Enrollment
103
Registered
2014-06-13
Start date
2010-12-31
Completion date
2011-03-31
Last updated
2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Keywords

I-gel, oropharyngeal leak pressure, head position

Brief summary

Airway management is one of the basic topics in anesthetic practice. Use of endotracheal intubation and face mask are standard methods to maintain an open airway widely adopted for many years. As a result of a search for more appropriate choices from the point of view of effectiveness, reliability and side effects, supraglottic airway devices (SGAD) have been developed. SGAD's are used for thyroid surgery, ear surgery, carotid endarterectomy, adenotonsillectomy and laser pharyngoplasty, which require a variety of head-neck positions. Changing the head and neck position leads to changes in the shape of the pharynx, which causes variation in the cuff pressure and oropharyngeal leak pressure. Oropharyngeal leak pressure values play a determining role in protecting the airway from high cuff pressure. Additionally it shows that the laryngeal mask is correctly placed and is a sign of the effectiveness of positive pressure ventilation. During surgery head-neck and trunk position may change. As a result there is a need for research evaluating the effect of head and neck position on oropharyngeal leak pressure during SGAD use. AIM The aim of this study is to compare the effect of different head and neck positions on the oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Additionally the placement duration, ease and success of these two supraglottic airway devices will be compared.

Detailed description

This prospective, randomized, double-blind study will receive permission from the Local Research Ethics Committee and after obtaining patients' informed consent, 103 patients with American society of anesthesiologists (ASA) classification group I-II, between 18-65 years, undergoing elective surgery with indications for supraglottic airway device placement were included in the study. All patients preoperatively evaluated and ASA and Mallampati classification recorded. All SGAD's inserted by the same experienced researcher. After placement of laryngeal mask, to standardize postoperative pharyngeal morbidity, cuff pressure (cuff pressure manometer, Ruch, Germany) was monitored. EXCLUSION CRITERIA: * Any neck or upper respiratory pathology * Those at risk of gastric content regurgitation/aspiration (previous upper Gastro-intestinal surgery, known hiatus hernia, Gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy) * Possibility of and those with history of difficult intubation (history of impossible intubation, Mallampati classification 3-4, sterno mental distance less than 12 cm, thyromental distance less than 6 cm, head extension less than 90 degrees, mouth opening less than 1.5 cm) * Those with low pulmonary compliance or high airway resistance (morbid obesity, lung disease) * Throat pain, dysphagia and dysphonia * Patients with cervical disc hernia Patients taken to the operating room were given standard monitoring before anesthesia induction. Patients were preoxygenated with 6 L/min oxygen for 3 minutes through a face mask. Anesthesia induction was provided by 0.02 mg/kg midazolam, 1-2 mcg/kg fentanyl, 1.5-2 mg/kg propofol and 0.5 mg/kg rocuronium. All patients have neuromuscular junction monitoring (TOF-GUARD, Biometer International A.S. DENMARK) and when TOF is zero SGAD was inserted with the standard method according to the firm's recommendations. During SGAD placement, if necessary additional dose of 0.5 mg/kg propofol was given depending on patient reaction. During this procedure cases were ventilated with 100% oxygen though a mask. STUDY GROUPS: Group U (UNIQUE): LMA- UNIQUE, inserted according to described standard method Group I (I-GEL ) : I-GEL, inserted with standard technique according to users manual For LMA-U the laryngeal mask cuff was inflated so that cuff pressure is less than 60 cm H2O with leak preventive volume. After the operation before the laryngeal mask was removed the cuff pressure was measured again and recorded. To check SGAD placement bilateral chest movement was observed and capnography be used to confirm a square wave shape. After SGAD was placed oropharyngeal leak test was completed. Oropharyngeal leak pressure were tested in both groups first in neutral head position, then at maximum extension and with head at maximum rotation to the right. In every position the leak measurement was made 60 seconds after position is changed. In order to prevent the SGAD from being seen by the researcher during the tests the patient's head was covered. Oropharyngeal leak pressure was measured with the ring system expiratory valve closed and 4 L/min flow. To prevent exposure of the lungs to barotrauma, when peak airway pressure reaches 40 cm H2O the expiratory valve was opened . Leak pressure was evaluated in two ways; 1. The stethoscope is placed above the patient's left thyroid part of the trachea and the sound of a leak is listened for 2. Checked when the aneroid manometer is held steady (manometer stability test) When the sound of the leak is heard, the pressure on the manometer were recorded separately in both situations. Anesthesia was maintained with 5% O2/air mix with 1.5-2.5% sevoflurane. Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), and heart rate (HR) values were measured and recorded immediately before anesthesia induction, immediately before airway device placement and at 1, 2, and 3 minutes after airway placement is checked. The time for successful placement (duration from mouth opening to first successful ventilation), number of attempts, and ease of placement were recorded. Ease of insertion: 1. no reaction 2. straining, retching 3. alternative airway management The Mallampati score, type of supraglottic airway device, type of operation and total duration of anesthesia were recorded. Any problems occurring during head and neck positions was noted. The cuff pressure was measured after surgery while the patient is still in deep anesthesia. When the patient is conscious the SGAD was removed and the duration of use was recorded (time from insertion to removal). After the SGAD is removed the presence of blood was evaluated 1. no blood 2. trace amounts of blood 3. definite amount of blood The patients throat pain, voice loss and difficulty swallowing were evaluated when leaving the recovery room and by telephone 24 hours later by a researcher blind to the insertion technique. To evaluate throat pain the VAS 10 (verbal analogue scale) was used EXPULSION CRITERIA: * Oxygen saturation by pulse oximetry values falling by 90% during airway insertion * Cases developing laryngospasm * Cases with incomplete records

Interventions

DEVICEGroup U (UNIQUE)

Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.

DEVICEI-GEL

Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff. I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ASA I-II * 18-65 years

Exclusion criteria

* Any neck or upper respiratory pathology * Those at risk of gastric content regurgitation/aspiration (previous upper gastro-intestina system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy) * Possibility of and those with history of difficult intubation (history of impossible intubation, Mallampati classification 3-4, sterno mental distance less than 12 cm, thyromental distance less than 6 cm, head extension less than 90 degrees, mouth opening less than 1.5 cm) * Those with low pulmonary compliance or high airway resistance (morbid obesity, lung disease) * Throat pain, dysphagia and dysphonia * Patients with cervical disc hernia

Design outcomes

Primary

MeasureTime frameDescription
Oropharyngeal Leak PressureImmediately after head and neck positioning is completedThe aim of this study is to compare the effect of different head and neck positions on the oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Head and neck positions are limited to neutral, extension and right laterally deviated.

Secondary

MeasureTime frameDescription
The Time for Successful Placement (Second)Baseline to first successful ventilation, in secondsDuration from mouth opening to first successful ventilation, in seconds
Number of AttemptsBaseline to first successful ventilation,The number of attempts until succesful placement of airway device
Ease of PlacementBaselineEase of placement: 1. no reaction 2. straining, retching
Incidence of Post-operative Sore Throatat postoperative 1st and 24th hoursPatients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, voice loss and difficulty swallowing , at postoperative 1st and 24th hours.

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
Group U (UNIQUE)
Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique. Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.
50
Group I (I-GEL ): Group I-GEL
Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For \> 90 kg no.5. I-GEL I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff. I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc
50
Total100

Baseline characteristics

CharacteristicGroup U (UNIQUE)Group I (I-GEL ): Group I-GELTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
50 Participants50 Participants100 Participants
Region of Enrollment
Turkey
50 participants50 participants100 participants
Sex: Female, Male
Female
23 Participants25 Participants48 Participants
Sex: Female, Male
Male
27 Participants25 Participants52 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 50
other
Total, other adverse events
0 / 500 / 50
serious
Total, serious adverse events
0 / 500 / 50

Outcome results

Primary

Oropharyngeal Leak Pressure

The aim of this study is to compare the effect of different head and neck positions on the oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Head and neck positions are limited to neutral, extension and right laterally deviated.

Time frame: Immediately after head and neck positioning is completed

ArmMeasureGroupValue (MEAN)Dispersion
Group U (UNIQUE)Oropharyngeal Leak Pressurewhen neutral position25.06 cm H20Standard Deviation 7.53
Group U (UNIQUE)Oropharyngeal Leak Pressurewhen extension position22.88 cm H20Standard Deviation 7.83
Group U (UNIQUE)Oropharyngeal Leak Pressurewhen right position27.30 cm H20Standard Deviation 7.23
Group I (I-GEL ): Group I-GELOropharyngeal Leak Pressurewhen neutral position28.24 cm H20Standard Deviation 8.29
Group I (I-GEL ): Group I-GELOropharyngeal Leak Pressurewhen extension position26.62 cm H20Standard Deviation 8.77
Group I (I-GEL ): Group I-GELOropharyngeal Leak Pressurewhen right position26.04 cm H20Standard Deviation 8.61
Secondary

Ease of Placement

Ease of placement: 1. no reaction 2. straining, retching

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Group U (UNIQUE)Ease of Placementno reaction49 participants
Group U (UNIQUE)Ease of Placementstraining, retching1 participants
Group I (I-GEL ): Group I-GELEase of Placementno reaction49 participants
Group I (I-GEL ): Group I-GELEase of Placementstraining, retching1 participants
Secondary

Incidence of Post-operative Sore Throat

Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, voice loss and difficulty swallowing , at postoperative 1st and 24th hours.

Time frame: at postoperative 1st and 24th hours

ArmMeasureValue (NUMBER)
Group U (UNIQUE)Incidence of Post-operative Sore Throat5 participants
Group I (I-GEL ): Group I-GELIncidence of Post-operative Sore Throat0 participants
Secondary

Number of Attempts

The number of attempts until succesful placement of airway device

Time frame: Baseline to first successful ventilation,

Population: The number of patients with succesful placement of airway device at the first attempt

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group U (UNIQUE)Number of AttemptsSuccesful First Attempt48 Participants
Group U (UNIQUE)Number of AttemptsSuccesful second Attempt2 Participants
Group U (UNIQUE)Number of AttemptsSuccesful third Attempt0 Participants
Group I (I-GEL ): Group I-GELNumber of AttemptsSuccesful First Attempt48 Participants
Group I (I-GEL ): Group I-GELNumber of AttemptsSuccesful second Attempt1 Participants
Group I (I-GEL ): Group I-GELNumber of AttemptsSuccesful third Attempt1 Participants
Secondary

The Time for Successful Placement (Second)

Duration from mouth opening to first successful ventilation, in seconds

Time frame: Baseline to first successful ventilation, in seconds

ArmMeasureValue (MEAN)Dispersion
Group U (UNIQUE)The Time for Successful Placement (Second)13.46 secondsStandard Deviation 2.6
Group I (I-GEL ): Group I-GELThe Time for Successful Placement (Second)12.14 secondsStandard Deviation 4.22

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026