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

Not Applicable

• Conditions: Comparison of Different Laryngeal Mask Wearing Methods
• Interventions: Device: direct laryngoskopy

• Registration Number: NCT04509960
• Lead Sponsor: Ankara Diskapi Training and Research Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-06-13
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-05
• Study Start: 2021-01-15
• Primary Completion: 2021-03-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
proseal laryngeal mask insertion with laryngoscope	direct laryngoskopy	with the help of direct laryngoscopy

Primary Outcome Measures

Name	Time	Method
laryngeal mask placement	First minute after laryngeal mask insertio	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.
complications of laryngeal mask insertion	Complications will be evaluated within 1 hour after patient recovery.	complications like sore throat, hoarseness, nausea, and vomiting or Bloodstain on the laryngeal mask.; we simply asked patients about them

Secondary Outcome Measures

Name	Time	Method
hemodynamic responce	Before putting on the Layngeal mask, it will record in mm Hg at 5 minutes for 1 minute and 20 minutes after wearing	mean blood pressure will record before LMA and post LMA used at first minute
oxygen saturation	Before putting on the Layngeal mask, it will record in %SpO2 at 5 minutes for 1 minute and 20 minutes after wearing	saturation will record before LMA and post LMA used at first minute
hemodynamic response	Before putting on the Layngeal mask, it will record in beats / minute at 5 minutes for 1 minute and 20 minutes after wearing	Heart rate will record before LMA and post LMA used at first minute
insertion time	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.	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
respiratory dynamics	The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute	The investigator will record the end-tidal CO2(mmHg) value from the mechanical ventilator after wearing the laryngeal mask.

Trial Locations

Locations (1)

University of Health Siences Diskapi Yildirim Beyazit T&R hospital; 🇹🇷 Ankara, Turkey