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

Comparison of Different Laryngeal Mask Wearing Methods Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04509960
• Other study ID #: LMA
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: January 2021
• Source: Ankara Diskapi Training and Research Hospital
• Contact: Filiz Akaslan
• Phone: 03125962553
• Email: flz_karaca[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Comparison of Different Laryngeal Mask Wearing Methods

Intervention

Device:
• direct laryngoskopy
Proseal Laryngeal mask inserted with direct laryngoskopy

Locations

Country	Name	City	State
Turkey	University of Health Siences Diskapi Yildirim Beyazit T&R hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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