Airway Management for Trigeminal Thermal Coagulation

Airway Management Clinical Trial

Official title:

Airway Management in Patients Undergoing Thermal Ganglion Gasseri Coagulation, a New Method - Preliminary Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990599
• Other study ID #: 1221/2012
• Status: Completed
• Phase: N/A
• First received: November 15, 2013
• Last updated: November 15, 2013
• Start date: July 2012

Study information

• Verified date: November 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Airway management of patients undergoing thermal coagulation of the Gasserian ganglion is very delicate. This is because of the specific operation site and moreover patients should recover quickly from anesthesia to follow verbal intraoperative commands of the surgeon. Endotracheal intubation or laryngeal mask of course hinders the patient from speaking. An obvious alternative airway management, as performed in this preliminary study, is a nasopharyngeal placed tube.

The purpose of the present study is to objectify the gas exchange in patients during this new ventilation technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing thermal coagulation of the Gasserian ganglion

Exclusion Criteria:

• Body weight over 100 kg

• Recurrent nasal bleeding

• Patients suffering from reflux disease

• Additional risk of aspiration (e.g. hernia diaphragmalis)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Airway Management

Intervention

Other:
• Nasopharyngeal Tube

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood gas exchange	Blood gas analyses will be determined at three time points perioperatively. The first measurement, at base line, will be performed preoperatively, the second one after puncture of the Gasserian ganglion and the third during the thermal coagulation of the Gasserian ganglion.	Before and during the neurosurgical intervention	No
Secondary	SpO2 oxygen saturation (pulse oximeter)		Before and during the neurosurgical intervention	No
Secondary	Hemodynamic parameters		Before and during the neurosurgical intervention	No