Effect of Different Supralottic Airway Devicess on Optic Nerve Sheath Diameter

NCT05499754 | Completed

• 1 other identifier: 2019/09
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Pressure Increase; Supraglottic Airway Device; Optic Nerve Sheath Diameter

Keywords

Supraglottic airway device; hemodynamic response; optic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

• OPTIC NERVE SHEATH DIAMETER

  effects of different types of laryngeal masks onoptic nerve sheath diameter

  10 min after using supraglottic airway devices

Study Arms (3)

pLMA(n=30)

Other: pLMA: PROSEAL LARYNGEAL MASK, sLMA : SUPREMA LARYNGEAL MASK, I-jel =I-GEL

sLMA(n=30)

Other: pLMA: PROSEAL LARYNGEAL MASK, sLMA : SUPREMA LARYNGEAL MASK, I-jel =I-GEL

I-jel(n=30)

Other: pLMA: PROSEAL LARYNGEAL MASK, sLMA : SUPREMA LARYNGEAL MASK, I-jel =I-GEL

Interventions

pLMA: PROSEAL LARYNGEAL MASK, sLMA : SUPREMA LARYNGEAL MASK, I-jel =I-GEL OTHER

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.

I-jel(n=30); pLMA(n=30); sLMA(n=30)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

90

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Gamze Küçükosman

Zonguldak, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: August 12, 2022
• Study Start: July 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)