Clinical trial NCT06527352: Risk of Gastric Reflux During Tulip vs GMA(Glottis Mask Airway) Airway
Official title: Comparison of Risk of Gastroesophageal Reflux During General Anesthesia With Tulip vs GMA(Glottis Mask Airway) Airway
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia
Keywords: general anesthesia
glottis mask airway
Tulip shaped tip
gastroesophageal reflux
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Glottis mask airway (GMA) is supraglottic airway device and is frequently used in patients undergoing general anesthesia. However, gastroesophageal reflux remains a risk during ventilation through supraglottic airway devices. The classical shaped GMA and tulip shaped GMA differ in the shape of their tips. And theoretically the tulip shaped tip fits the larynx better. This study aims to compare the incidence of gastroesophageal reflux during ventilation through classical shaped vs tulip shaped glottis mask airway.


Eligibility criteria: Inclusion Criteria:

* age≥18 years old
* scheduled for surgery under general anesthesia with laryngeal mask airway

Exclusion Criteria:

* American society of anesthesiologists status score higher than 3
* morbid obesity (body mass index higher than 40 kg/m2)
* with high risk of gastroesophageal reflux
* with risk of difficult airway
* with airway disease

Primary outcomes:
measure: pH value of secretion on the tip of glottis mask airway at the end of surgery
timeFrame: at the end of surgery
Secondary outcomes:
measure: number of participants with a pH value of secretion on the tip of glottis mask airway less than 4.1
timeFrame: at the end of surgery
measure: Oropharyngeal leak pressure
timeFrame: from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
measure: duration of inserting glottis mask airway
timeFrame: from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
measure: number of insertion to achieve successful positioning of glottis mask airway
timeFrame: from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
measure: duration of establishing appropriate ventilation
timeFrame: from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute
measure: incidence of epiglottis suppression
timeFrame: from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
measure: number of needs for modulating the position of glottis airway mask during surgery
timeFrame: from insertion of glottis mask airway to end of surgery, at an average of 2 hours
measure: scale of difficulty of inserting gastric tube
timeFrame: from insertion of glottis mask airway to start of surgery, at an average of 10 minutes
measure: incidence of blood on the tip of glottis airway mask
timeFrame: from end of surgery to withdrawal of glottis airway mask, at an average of 5 minutes
measure: score of satisfaction of anesthesiologist to glottis airway mask
timeFrame: from insertion of glottis mask airway to withdrawal of glottis airway mask, at an average of 2 hours
measure: incidence of glottis airway mask related adverse events by 24 hours after surgery
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, Air Force Medical University
state: Shaanxi
Study officials:
References:
citation: Lemos J, De Oliveira GS Jr, de Pereira Cardoso HE, Lemos LD, de Carvalho LR, Modolo NS. Gastric regurgitation in patients undergoing gynecological laparoscopy with a laryngeal mask airway: a prospective observational study. J Clin Anesth. 2017 Feb;36:32-35. doi: 10.1016/j.jclinane.2016.07.038. Epub 2016 Nov 11.
citation: Nakanishi T, Sakamoto S, Yoshimura M, Toriumi T. AutoFlow(R) versus volume-controlled ventilation for laparoscopic gynecological surgery using LMA(R) ProSeal: a randomized controlled trial. BMC Anesthesiol. 2021 Jun 28;21(1):181. doi: 10.1186/s12871-021-01406-6.
citation: Liu Y, Song Y, Wang M, Yang M, Shen H, Wang Z, Chen L, Yang J, Gong S, Yu Y, Shi Z, Zhang W, Zou X, Sun X, Wang Y, Fu Q, Cao J, Mi W. LMA(R) protector in patients undergoing laparoscopic surgeries: a multicenter prospective observational study. BMC Anesthesiol. 2021 Dec 20;21(1):318. doi: 10.1186/s12871-021-01535-y.
citation: Bhardwaj M, Dhania S, Kaur K, Lal J, Priya, Singhal SK. Comparison of oropharyngeal leak pressure of LMA Protector and LMA ProSeal in anaesthetised paralysed patients - A randomised controlled trial. Indian J Anaesth. 2023 Nov;67(Suppl 4):S245-S250. doi: 10.4103/ija.ija_403_23. Epub 2023 Nov 21.