Airway ManagementNCT01990599
Airway Management for Trigeminal Thermal Coagulation
A study testing Nasopharyngeal Tube in people with Airway Management, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Management
- What is being tested?
- Nasopharyngeal Tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing thermal coagulation of the Gasserian ganglion
Who cannot join
- Body weight over 100 kg
- Recurrent nasal bleeding
- Patients suffering from reflux disease
- Additional risk of aspiration (e.g. hernia diaphragmalis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Airway Management
- Being tested
- Nasopharyngeal Tube
- Keywords
- nasopharyngeal tube, airway management, thermal coagulation of the Gasserian ganglion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal TubeOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nasopharyngeal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and during the neurosurgical intervention
Secondary outcomes (2)
SpO2 oxygen saturation (pulse oximeter)
Measured: Before and during the neurosurgical intervention
Hemodynamic parameters
Measured: Before and during the neurosurgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang SCHRAMM, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990599
- Sponsor's protocol ID
- 1221/2012
- Status last verified
- Nov 2013
- First submitted
- 15 Nov 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management in Patients Undergoing Thermal Ganglion Gasseri Coagulation, a New Method - Preliminary Results
- ClinicalTrials.gov ID
- NCT01990599
- Acronym / sponsor ID
- 1221/2012
- Conditions
- Airway Management
- Keywords
- nasopharyngeal tube, airway management, thermal coagulation of the Gasserian ganglion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal Tube | Other | Other: Nasopharyngeal TubeEvery patient undergoing trigeminal thermal coagulation of the Gasserian ganglion will be ventilated by a nasopharyngeal placed ID 5mm tube during the whole neurosurgical intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thermal coagulation of the Gasserian ganglion
Key exclusion criteria (4 listed)
- Body weight over 100 kg
- Recurrent nasal bleeding
- Patients suffering from reflux disease
- Additional risk of aspiration (e.g. hernia diaphragmalis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal Tube | Other | Nasopharyngeal Tube |
Primary outcome
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.
2 secondary outcomes
SpO2 oxygen saturation (pulse oximeter)
Time frame: Before and during the neurosurgical intervention
Hemodynamic parameters
Time frame: Before and during the neurosurgical intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
Related trials for Airway Management
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngeal Tube in people with Airway Management, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood gas exchange (time frame: Before and during the neurosurgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.