Different Ways of Airway Management in Elective Minor Surgeries in Geriatric Patients

Comparison of Airway Placement Conditions and Postoperative Effects of Laryngoscope-guided Laryngeal Mask Placement Methods in Sniffing Position in Geriatric Edentulous Patients

different ways of airway management in elective minor surgeries of geriatric patients

Study Overview

• Status: Unknown
• Conditions: Comparison of Different Laryngeal Mask Wearing Methods
• Intervention / Treatment: Device: direct laryngoskopy

Detailed Description

The investigators will used two different ways of pro-seal laryngeal mask insertion technique (laryngoscopy- guided technique or the standard technique) in elective minor surgeries of geriatric toothless patients.

The investigators will record the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. The investigators will record the laryngeal mask insertion time and oropharyngeal leakage pressure. The investigators will evaluate the placement of a laryngeal mask according to young criteria. The development and severity of coughing, retching, laryngospasm, extremity, and head movement during laryngeal mask placement will be recorded. Bloodstains, sore throat, hoarseness will be recorded on the mask that may develop due to laryngeal mask placement. The investigators will use the Briacombe scoring and Campbell category system to assess the position of laryngeal mask airway devices.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • university of health siences diskapi yildirim beyazit T&R hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ASA physical status I or II or III
2. Who were scheduled to minor elective ambulatory surgery (e.g. urology operations)
3. Patients undergoing general anesthesia
4. Those who are planned to wear a laryngeal mask for surgical procedure

Exclusion Criteria:

1. patients with full stomach
2. A history of gastric reflux
3. A history of convulsions, cardiovascular or neuromuscular disease
4. Allergies to the study drugs
5. obese (Body mass index (BMI) ≥ 40 kg / m2)
6. suspected difficult airway and hyper-reactive airway disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: proseal laryngeal mask insertion; no intervention
EXPERIMENTAL: proseal laryngeal mask insertion with laryngoscope; with the help of direct laryngoscopy	Device: direct laryngoskopy; Proseal Laryngeal mask inserted with direct laryngoskopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
laryngeal mask placement	To evaluate the best fiberoptic bronchoscopic view while insertion of pro-Seal laryngeal mask either in a classic way, or with the help of laryngoscope. The fibreoptic evaluation Includes 4, only vocal cords visible; 3, vocal cords plus posterior epiglottis visible 2, vocal cords plus anterior epiglottis visible ; 1, vocal cords not seen.	First minute after laryngeal mask insertio
complications of laryngeal mask insertion	complications like sore throat, hoarseness, nausea, and vomiting or Bloodstain on the laryngeal mask. we simply asked patients about them	Complications will be evaluated within 1 hour after patient recovery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemodynamic response	Heart rate will record before LMA and post LMA used at first minute	Before putting on the Layngeal mask, it will record in beats / minute at 5 minutes for 1 minute and 20 minutes after wearing
insertion time	Insertion time was defined from the time of removal of the facemask to the time of the appearance of first capnography upstroke. we assessed this outcome stopwatch	The investigator will record the insertion time in seconds from the moment the laryngeal mask airway passes the incisors until the end-tidal CO2 is visible.
respiratory dynamics	The investigator will record the (tidal volume(ml) value from the mechanical ventilator after wearing the laryngeal mask.	The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
hemodynamic responce	mean blood pressure will record before LMA and post LMA used at first minute	Before putting on the Layngeal mask, it will record in mm Hg at 5 minutes for 1 minute and 20 minutes after wearing
oxygen saturation	saturation will record before LMA and post LMA used at first minute	Before putting on the Layngeal mask, it will record in %SpO2 at 5 minutes for 1 minute and 20 minutes after wearing
respiratory dynamics	The investigator will record the peak airway pressure (cmH2O) value from the mechanical ventilator after wearing the laryngeal mask.	The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
respiratory dynamics	The investigator will record the end-tidal CO2(mmHg) value from the mechanical ventilator after wearing the laryngeal mask.	The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute

Collaborators and Investigators

• Sponsor: Ankara Diskapi Training and Research Hospital

Publications and helpful links

General Publications

• Chandan SN, Sharma SM, Raveendra US, Rajendra Prasad B. Fiberoptic assessment of laryngeal mask airway placement: a comparison of blind insertion and insertion with the use of a laryngoscope. J Maxillofac Oral Surg. 2009 Jun;8(2):95-8. doi: 10.1007/s12663-009-0025-8. Epub 2009 Aug 11.
• Kim GW, Kim JY, Kim SJ, Moon YR, Park EJ, Park SY. Conditions for laryngeal mask airway placement in terms of oropharyngeal leak pressure: a comparison between blind insertion and laryngoscope-guided insertion. BMC Anesthesiol. 2019 Jan 5;19(1):4. doi: 10.1186/s12871-018-0674-6.
• Choo CY, Koay CK, Yoong CS. A randomised controlled trial comparing two insertion techniques for the Laryngeal Mask Airway Flexible in patients undergoing dental surgery. Anaesthesia. 2012 Sep;67(9):986-90. doi: 10.1111/j.1365-2044.2012.07167.x. Epub 2012 Jun 11.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 15, 2021
• Primary Completion (ANTICIPATED): March 30, 2021
• Study Completion (ANTICIPATED): April 30, 2021

Study Registration Dates

• First Submitted: June 13, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (ACTUAL): August 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: laryngeal mask
• Other Study ID Numbers: LMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No