NCT01990599

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

November 15, 2013

Last Update Submit

November 15, 2013

Conditions

Airway Management

Keywords

nasopharyngeal tubeairway managementthermal coagulation of the Gasserian ganglion

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • SpO2 oxygen saturation (pulse oximeter)

    Before and during the neurosurgical intervention

  • Hemodynamic parameters

    Before and during the neurosurgical intervention

Study Arms (1)

Nasopharyngeal Tube

OTHER

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

Interventions

Nasopharyngeal TubeOTHER
Nasopharyngeal Tube

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients undergoing thermal coagulation of the Gasserian ganglion

You may not qualify if:

  • Body weight over 100 kg
  • Recurrent nasal bleeding
  • Patients suffering from reflux disease
  • Additional risk of aspiration (e.g. hernia diaphragmalis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr.

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 21, 2013

Study Start

July 1, 2012

Primary Completion

June 1, 2013

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

AU(1)