Effect of Different Supralottic Airway Devicess on Optic Nerve Sheath Diameter

NCT ID: NCT05499754

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Pressure Increase Supraglottic Airway Device Optic Nerve Sheath Diameter

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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pLMA(n=30)

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

Intervention Type 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.

sLMA(n=30)

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

Intervention Type 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: PROSEAL LARYNGEAL MASK, sLMA : SUPREMA LARYNGEAL MASK, I-jel =I-GEL

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zonguldak Bulent Ecevit University

OTHER

Sponsor Role lead

Responsible Party

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Gamze Küçükosman

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gamze Küçükosman

Zonguldak, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019/09

Identifier Type: -

Identifier Source: org_study_id

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