Cardiac or Respiratory Arrest, AnaesthesiaNCT01909310
Head Positions to Open the Airway IV
A study testing head extension, neutral position and anaesthesiologist´s position in people with Cardiac or Respiratory Arrest, Anaesthesia, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
After routine induction of general anaesthesia peak airway pressure (= P max) and other respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and without head support in three different head positions: neutral position, reclination of the head, a position deemed ideal by the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac or Respiratory Arrest, Anaesthesia
- What is being tested?
- head extension, neutral position and anaesthesiologist´s position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2013to 1 Apr 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male and female patients ≥ 18 years
- elective operations in general anaesthesia
- patient´s written informed consent
- American Society of Anesthesiology scale I-III
Who cannot join
- non fasting patient
- body mass index > 35 kg/m2
- anamnestic cervical spine pathologies or other peripheral neurological deficiences due to pathologies of the cervical spine
- malformations of the head or upper airway
- history of perforation of stomach or esophagus
- anamnestic hiatus hernia or reflux
- acute respiratory infection or obstructive airway disease
Trial locations and contacts
1 site in 1 country.
Austria1 site
Klinik für Anästhesie und Allgemeine Intensivmedizin, Medizinische Universität Innsbruck, Anichstraße 35
Innsbruck, 6020
About this study
Official title: Head Positions to Open the Upper Airway IV
After routine induction of general anaesthesia peak airway pressure (= P max) and other respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and without head support in three different head positions: neutral position, reclination of the head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on different head positions;
- Being tested
- head extension, neutral position, anaesthesiologist´s position
- Keywords
- anesthesia, cardiac arrest, resuscitation, ventilation
- Medical subject headings
- Apnea, Heart Arrest, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head extensionProcedure or surgery
the lungs are ventilated with the patient´s head extended
neutral positionProcedure or surgery
the lungs are ventilated with the patient´s head in neutral position
anaesthesiologist´s positionProcedure or surgery
the lungs are ventilated with the patient´s head positioned deemed ideal by the anaesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| with head support | Active comparator | patients are ventilated with their heads positioned on a support Receives: Procedure: head extension; Procedure: neutral position; Procedure: anaesthesiologist´s position |
| without head support | Sham comparator | patients are ventilated without head support Receives: Procedure: head extension; Procedure: neutral position; Procedure: anaesthesiologist´s position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak airway pressure
Measured: peak airway pressure is measured over one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac or Respiratory Arrest, AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Paal, PD MD MBA EDAIC EDIC, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909310
- Sponsor's protocol ID
- UN5155 327/4.10
- Status last verified
- Mar 2017
- First submitted
- 24 Jul 2013
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Positions to Open the Upper Airway IV
- ClinicalTrials.gov ID
- NCT01909310
- Acronym / sponsor ID
- UN5155 327/4.10
- Keywords
- anesthesia, cardiac arrest, resuscitation, ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 26 Jul 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.
After routine induction of general anaesthesia peak airway pressure (= P max) and other respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and without head support in three different head positions: neutral position, reclination of the head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on different head positions;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with head support | Active comparator | Procedure: head extension, Procedure: neutral position, Procedure: anaesthesiologist´s positionpatients are ventilated with their heads positioned on a support |
| without head support | Sham comparator | Procedure: head extension, Procedure: neutral position, Procedure: anaesthesiologist´s positionpatients are ventilated without head support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male and female patients ≥ 18 years
- elective operations in general anaesthesia
- patient´s written informed consent
- American Society of Anesthesiology scale I-III
Key exclusion criteria (7 listed)
- non fasting patient
- body mass index > 35 kg/m2
- anamnestic cervical spine pathologies or other peripheral neurological deficiences due to pathologies of the cervical spine
- malformations of the head or upper airway
- history of perforation of stomach or esophagus
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 |
|---|---|---|
| head extensionthe lungs are ventilated with the patient´s head extended | Procedure or surgery | with head support, without head support |
| neutral positionthe lungs are ventilated with the patient´s head in neutral position | Procedure or surgery | with head support, without head support |
| anaesthesiologist´s positionthe lungs are ventilated with the patient´s head positioned deemed ideal by the anaesthesiologist | Procedure or surgery | with head support, without head support |
Primary outcome
Peak airway pressure
Time frame: peak airway pressure is measured over one minute
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 23 Mar 2017.
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 head extension, neutral position and anaesthesiologist´s position in people with Cardiac or Respiratory Arrest, Anaesthesia, run by Medical University Innsbruck 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 4 inclusion and 7 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 23 Mar 2017. 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. Some participants in this study may receive a placebo. 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?
Peak airway pressure (time frame: peak airway pressure is measured over one minute). 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 23 Mar 2017.