Effect of Different Supralottic Airway Devicess on Optic Nerve Sheath Diameter

Intracranial Pressure Increase Clinical Trial

Official title:

The Effect of Supralottic Airway Devicess on Hemodynamic Response and Optic Nerve Sheath Diameter. PROSEAL LMA, SUPREMA LMA, I-JEL LMA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05499754
• Other study ID #: 2019/09
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2022
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Direct laryngoscopy and tracheal intubation are associated with increases in intraocular pressure (IOP), intracranial pressure (ICP), heart rate (HR), and blood pressure. The use of supraglottic airway devices (SADs) are known to be beneficial in overcoming the disadvantages of laryngoscopy and tracheal intubation, especially ocular and pressure stress responses. In recent years, it has been reported that ultrasonographic measurement of optic nerve sheath diameter (ONSD) can be used in the diagnosis of increased ICP. The aim of our study is to compare the effects of Proseal laryngeal mask airway (pLMA), Suprem laryngeal mask airway (sLMA) and I-gel on hemodynamic response and ONSD during insertion in adult patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA physical status of I-II
• elective surgery
• non-ophthalmic procedures
• 1-2 h duration
• general anaesthesia
• supine position

Exclusion Criteria:

• Mallampati and ASA status =III,
• a history or suspect of difficult airway,
• previous intracranial/ocular surgery,
• cerebral edema/high intracranial pressure,
• glaucoma,
• uncontrolled hypertension -, diabetic retinopathy,
• obstetric patients,
• those who refused to participate in the study

Related Conditions & MeSH terms

• Intracranial Hypertension
• Intracranial Pressure Increase
• Optic Nerve Sheath Diameter
• Supraglottic Airway Device

Intervention

Other:
• pLMA: PROSEAL LARYNGEAL MASK, sLMA : SUPREMA LARYNGEAL MASK, I-jel =I-GEL
a SAD was inserted by all anaesthetists participating in the study had at least 3 years experience of airway management and were experienced with both the pLMA, sLMA and I-jel. Inadequate ventilation after two attempts was considered a failed placement, and these patients were excluded, while the practitioner was freed to use an alternative airway device.

Locations

Country	Name	City	State
Turkey	Gamze Küçükosman	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OPTIC NERVE SHEATH DIAMETER	effects of different types of laryngeal masks onoptic nerve sheath diameter	10 min after using supraglottic airway devices