AnaesthesiaNCT01041352
Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position
A study testing laryngeal mask and endotracheal tube in people with Anaesthesia and Adverse Effects, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to compare anaesthesia (for back surgery) using endotracheal intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone position on the operation table) as regards advantages… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anaesthesia, Adverse Effects
- What is being tested?
- laryngeal mask and endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Sep 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for backsurgery of an espected duration less than 2 hours,
- Age 18-70 years,
- ASA (american society of anaaesthesiology) class 1-2,
- Normal airways
Who cannot join
- Body mass index >35
- Expected time of surgery > 2 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position. Advantages, Adverse Effects and Time Consumation for the Two Methods.
The aim of the study is to compare anaesthesia (for back surgery) using endotracheal intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone position on the operation table) as regards advantages, adverse effects and time spent. The anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium). Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients 18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an estimated duration of less than 2 hours.
Adverse effects (related to the placement on the operation table i.e. pain in the arms or shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence from the anaesthesia are registered. The hypothesis is that the method using the laryngeal mask is faster and with fewer adverse effects.
- Conditions
- Anaesthesia, Adverse Effects
- Being tested
- laryngeal mask, endotracheal tube
- Keywords
- anaesthesia, laryngeal mask, prone position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal maskDevice
LMA Proseal
endotracheal tubeDevice
Unomedical endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal group | Active comparator | airway management: endotracheal tube Receives: Device: endotracheal tube |
| laryngeal mask group | Active comparator | airway management: laryngeal mask Receives: Device: laryngeal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of anaesthesia
Measured: 2 years
Secondary outcomes (1)
adverse effects using the 2 methods
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karsten Skovgaard Olsen, Glostrup University Hospital, Copenhagen
- Investigators
- Karsten S Olsen, MD, DMSc, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041352
- Sponsor's protocol ID
- Laryngeal mask or endotracheal
- Status last verified
- Jan 2012
- First submitted
- 30 Dec 2009
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Olsen KS, Petersen JT, Pedersen NA, Rovsing L. Self-positioning followed by induction of anaesthesia and insertion of a laryngeal mask airway versus endotracheal intubation and subsequent positioning for spinal surgery in the prone position: a randomised clinical trial. Eur J Anaesthesiol. 2014 May;31(5):259-65. doi: 10.1097/EJA.0000000000000004.
PubMed 24247413
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position. Advantages, Adverse Effects and Time Consumation for the Two Methods.
- ClinicalTrials.gov ID
- NCT01041352
- Acronym / sponsor ID
- Laryngeal mask or endotracheal
- Conditions
- Anaesthesia, Adverse Effects
- Keywords
- anaesthesia, laryngeal mask, prone position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 31 Dec 2009 (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.
The aim of the study is to compare anaesthesia (for back surgery) using endotracheal intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone position on the operation table) as regards advantages, adverse effects and time spent. The anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium). Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients 18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an estimated duration of less than 2 hours.
Adverse effects (related to the placement on the operation table i.e. pain in the arms or shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence from the anaesthesia are registered. The hypothesis is that the method using the laryngeal mask is faster and with fewer adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal group | Active comparator | Device: endotracheal tubeairway management: endotracheal tube |
| laryngeal mask group | Active comparator | Device: laryngeal maskairway management: laryngeal mask |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for backsurgery of an espected duration less than 2 hours,
- Age 18-70 years,
- ASA (american society of anaaesthesiology) class 1-2,
- Normal airways
Key exclusion criteria (2 listed)
- Body mass index >35
- Expected time of surgery > 2 hours
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 |
|---|---|---|
| laryngeal maskLMA Proseal | Device | laryngeal mask group |
| endotracheal tubeUnomedical endotracheal tube | Device | Endotracheal group |
Primary outcome
time of anaesthesia
Time frame: 2 years
1 secondary outcome
adverse effects using the 2 methods
Time frame: 2 years
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 18 Jan 2012.
- Derived from this study: PubMed 24247413Olsen KS, Petersen JT, Pedersen NA, Rovsing L. Self-positioning followed by induction of anaesthesia and insertion of a laryngeal mask airway versus endotracheal intubation and subsequent positioning for spinal surgery in the prone position: a randomised clinical trial. Eur J Anaesthesiol. 2014 May;31(5):259-65. doi: 10.1097/EJA.0000000000000004.
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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.
Karsten S Olsen, MD, DMSc study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laryngeal mask and endotracheal tube in people with Anaesthesia and Adverse Effects, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 2 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 18 Jan 2012. 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 Denmark. 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?
time of anaesthesia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01041352, which also lists 1 linked publication.
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 18 Jan 2012.