Airway Management for Trigeminal Thermal Coagulation

November 15, 2013 updated by: Wolfgang SCHRAMM, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nasopharyngeal Tube
Every patient undergoing trigeminal thermal coagulation of the Gasserian ganglion will be ventilated by a nasopharyngeal placed ID 5mm tube during the whole neurosurgical intervention.
Other: Nasopharyngeal Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood gas exchange
Time Frame: Before and during the neurosurgical intervention
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

Secondary Outcome Measures

Outcome Measure
Time Frame
SpO2 oxygen saturation (pulse oximeter)
Time Frame: Before and during the neurosurgical intervention
Before and during the neurosurgical intervention
Hemodynamic parameters
Time Frame: Before and during the neurosurgical intervention
Before and during the neurosurgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 15, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1221/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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