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LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

Not Applicable
Completed
Conditions
Anesthesia
Airway
Interventions
Procedure: Group 2
Procedure: Group 1
Procedure: Group 3
Registration Number
NCT06174896
Lead Sponsor
Ondokuz Mayıs University
Brief Summary

Our study aimed to compare the manual placement, direct laryngoscopy and video laryngoscopy assisted placement techniques of LMA Proseal, a new generation laryngeal mask (LMA), and to find an effective placement technique that does not allow airway leakage in one go.

Detailed Description

LMA is an airway device frequently used in pediatric anesthesia. It is preferred for short interventions because it is less invasive compared to intubation. However, problems such as not being fully seated, slipping, and leakage can be encountered during placement. Multiple attempts after unsuccessful placement may cause undesirable results such as edema and sore throat. The aim in this study is to reveal the most accurate placement technique and to transfer this method to clinical applications.

Our research is a prospective, randomized controlled method study.

Patients will be divided into 3 groups.

Group 1:(Standard technique)

Group 2:(Placement with direct laryngoscopy)

Group 3:(Placement with the aid of video laryngoscopy)

After LMA Proseal placement, airway sealing pressures will be measured with appropriate technique. Airway tightness pressure measurement will be made with the technique accepted in the literature through the sensors in the anesthesia machine.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
Inclusion Criteria
  • 1-10 years old
  • Between 5-40 kg
  • ASA (American Society of Anesthesiologists) physical score I/II
  • Cases undergoing elective surgery lasting less than 90 minutes
Exclusion Criteria
  • Patients who are expected to have a difficult airway
  • Those with potential regurgitation risk (severe GER, presence of hiatal hernia)
  • Those who will undergo head and neck surgery, laparoscopic surgery
  • Those who will undergo surgery in the prone position
  • Emergency surgical interventions
  • Those who need muscle relaxants
  • Presence of intraoral abscess, pharyngeal pathology
  • Those who have had an upper or lower respiratory tract infection in the last 4 weeks
  • History of allergy to the drugs to be used
  • Failure of patients and their relatives to give consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 2Group 2Placement with direct laryngoscopy
Group 1Group 1Placement with standard technique
Group 3Group 3Placement with the aid of video laryngoscopy
Primary Outcome Measures
NameTimeMethod
Oropharyngeal leak pressurewithin 2-3 minutes after laryngeal mask insertion before start of surgery

Oropharyngeal leak pressure (OLP) will be measured by closing the adjustable pressure limiting valve on the anesthesia machine. The fresh gas flow was adjusted to 3 L/min. When the APL (Adjustable pressure limiting) valve was closed and manually ventilated. The leak sound that occurs during ventilation will be auscultated. The first peak airway pressure at which the leak occurs will be recorded as the oropharyngeal leak pressure.

After successful insertion, lma proseal location will be evaluated with fiberoptic imaging.

Secondary Outcome Measures
NameTimeMethod
Need for optimization maneuversintraoperative period

It will be recorded whether additional maneuvering is performed for optimal placement. LMA rotation, jaw thrust, head extension, and flexion will be use as optimization maneuvers.

Blood pressurePreoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

Measure blood pressure in millimeter of mercury by non-invasive blood pressure.

İnsertion timeintraoperative period

LMA insertion time (time from LMA handling to first wave formation in capnography)

Number of placement attemptsintraoperative period

The number of attempts for optimal placement will be recorded

Peripheral oxygen saturationPreoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

Measure peripheral oxygen saturation per minute by pulse oximeter.

Complicationsintraoperative and postoperative day 1.

İnvestigate the existence of complications that may be encountered in the routine after LMA placement and removal.

Heart ratePreoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

Measure heart rate in beats per minute by electrocardiography monitor.

Trial Locations

Locations (1)

Ondokuz Mayis University

🇹🇷

Samsun, Turkey

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