Airway, Anesthesia
Conditions
Keywords
supraglottic airway device, pediatric population
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.
Interventions
PROCEDUREGroup 1
The LMA Proseal will be inserted directly by hand, without the use of any laryngoscope, as recommended in the instruction manual. The cuff will be gently guided along the hard palate where it is pushed into the hypopharynx and increased resistance is felt, and the cuff will be placed towards the hypopharynx.
PROCEDUREGroup 2
Appropriately sized laryngoscope blade will be used and after the location of the epiglottis is determined, the tongue and epiglottis will be lifted forward. Then, LMA Proseal will be placed at the point where resistance is felt at a level where the proximal edge of the mask can be seen.
PROCEDUREGroup 3
After the video laryngoscope is placed with an appropriately sized blade, the location of the epiglottis and vocal cords will be determined and the LMA Proseal will be placed at the point where slight resistance is encountered after the epiglottis is lifted. proximal aspect of LMA
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based Research Randomizer (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the methods which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.
Intervention model description
A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous 2013)'.
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal leak pressure | within 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
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Preoperatively, 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 time | intraoperative period | LMA insertion time (time from LMA handling to first wave formation in capnography) |
| Need for optimization maneuvers | intraoperative 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. |
| Number of placement attempts | intraoperative period | The number of attempts for optimal placement will be recorded |
| Heart rate | Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. | Measure heart rate in beats per minute by electrocardiography monitor. |
| Peripheral oxygen saturation | Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. | Measure peripheral oxygen saturation per minute by pulse oximeter. |
| Complications | intraoperative and postoperative day 1. | İnvestigate the existence of complications that may be encountered in the routine after LMA placement and removal. |
Countries
Turkey (Türkiye)
Outcome results
None listed