ObeseTTINCT01827085
Time to Intubation (TTI) of Obese Patients. A Comparison Macintosh Laryngoscope and Stortz Video Laryngoscope
An observational study of Obese, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The purpose of the study is to investigate wether the use of the Stortz video laryngoscope will render in shorter time for the intubation of obese patients compared with the use of a conventional Macintosh laryngoscope. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obese
- What is being tested?
- Conventional Macintosh laryngoscope and Stortz videolaryngoscope
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- May 2012to Sep 2015
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: In-patients from the University hospital of Orebro who will go through planned surgery
Who may be able to join
- Age 18-60
- Obesity defined as BMI > 35
- ASA 1-3
Who cannot join
- -known or suspected difficult airway
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Anaethesia and Intensive Care, University Hospital Örebro
Örebro, 70351
About this study
Official title: Time to Intubation in Obese Patients. A Comparison Between Macintosh Laryngoscope and Stortz Video Laryngoscope
The purpose of the study is to investigate wether the use of the Stortz video laryngoscope will render in shorter time for the intubation of obese patients compared with the use of a conventional Macintosh laryngoscope.
Read the detailed description
Obese patients are prone to develop desaturation soon after initiation of anaesthesia compared to patients of normal body weight. It is therefore important to keep the time from when spontaneous breathing to when the airway is secured with a orotracheal tube as short as possible. We will therefore investigate if it is possible to shorten this time by using a Stortz videolaryngoscope.
Patients 18-60 years with ASA grade 1-3 and BMI < 35 that turn up for planned surgery that demands the use of orotracheal tubing and controlled ventilation will be randomly and consecutively enrolled in either of two groups. Patients in both groups will be anaesthetised with the same combination of drugs using Propofol and Remifentanyl or Fentanyl for induction of sleep, combined with Rocuronium for muscle relaxation.
After the induction and relaxation the intubation will be facilitated using either of two laryngoscopes. In the first group a conventional Macintosh laryngoscope, and in the second group a Stortz videolaryngoscope will be used. The time to intubation is defined as the time from grabbing the laryngoscope to when the tube has been inserted and end-tidal carbon dioxide appears on the monitor. Our hypothesis is that we will be able to achieve a faster intubation with the use of videolaryngoscope.
- Conditions
- Obese
- Being tested
- Conventional Macintosh laryngoscope, Stortz videolaryngoscope
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Macintosh laryngoscopeDevice
Stortz videolaryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope | Patients will be intubated with a conventional Machintosh laryngoscope Receives: Device: Conventional Macintosh laryngoscope | |
| Videolaryngoscope | Intubation with Stortz video laryngoscope Receives: Device: Stortz videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation seconds (s)
Measured: Up to 1 minute
Secondary outcomes (4)
Presence and level of postoperational throat pain
If throat pain is present, we will use a visual analogue scale to evaluate the level of throat pain 1h, 24h, 72h and 96h after extubation.
Measured: 1 hour to 96 hours postoperative
Ease of intubation
Measured: Two minutes
Incidence of trauma in each group
Measured: Two minutes
Number of attempts of intubation
Measured: Two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startMay 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex de Leon, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827085
- Sponsor's protocol ID
- EPN2012/015
- Acronym
- TTI
- Status last verified
- Oct 2016
- First submitted
- 26 Mar 2013
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Intubation in Obese Patients. A Comparison Between Macintosh Laryngoscope and Stortz Video Laryngoscope
- ClinicalTrials.gov ID
- NCT01827085
- Acronym / sponsor ID
- TTI / EPN2012/015
- Conditions
- Obese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Apr 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.
The purpose of the study is to investigate wether the use of the Stortz video laryngoscope will render in shorter time for the intubation of obese patients compared with the use of a conventional Macintosh laryngoscope.
Detailed description
Obese patients are prone to develop desaturation soon after initiation of anaesthesia compared to patients of normal body weight. It is therefore important to keep the time from when spontaneous breathing to when the airway is secured with a orotracheal tube as short as possible. We will therefore investigate if it is possible to shorten this time by using a Stortz videolaryngoscope.
Patients 18-60 years with ASA grade 1-3 and BMI < 35 that turn up for planned surgery that demands the use of orotracheal tubing and controlled ventilation will be randomly and consecutively enrolled in either of two groups. Patients in both groups will be anaesthetised with the same combination of drugs using Propofol and Remifentanyl or Fentanyl for induction of sleep, combined with Rocuronium for muscle relaxation.
After the induction and relaxation the intubation will be facilitated using either of two laryngoscopes. In the first group a conventional Macintosh laryngoscope, and in the second group a Stortz videolaryngoscope will be used. The time to intubation is defined as the time from grabbing the laryngoscope to when the tube has been inserted and end-tidal carbon dioxide appears on the monitor. Our hypothesis is that we will be able to achieve a faster intubation with the use of videolaryngoscope.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope | – | Device: Conventional Macintosh laryngoscopePatients will be intubated with a conventional Machintosh laryngoscope |
| Videolaryngoscope | – | Device: Stortz videolaryngoscopeIntubation with Stortz video laryngoscope |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- In-patients from the University hospital of Orebro who will go through planned surgery
Key inclusion criteria (3 listed)
- Age 18-60
- Obesity defined as BMI > 35
- ASA 1-3
Key exclusion criteria (1 listed)
- -known or suspected difficult airway
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 |
|---|---|---|
| Conventional Macintosh laryngoscope | Device | Macintosh laryngoscope |
| Stortz videolaryngoscope | Device | Videolaryngoscope |
Primary outcome
Time to intubation seconds (s)
Time frame: Up to 1 minute
4 secondary outcomes
Presence and level of postoperational throat pain
Time frame: 1 hour to 96 hours postoperative
Ease of intubation
Time frame: Two minutes
Incidence of trauma in each group
Time frame: Two minutes
Number of attempts of intubation
Time frame: Two minutes
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 7 Oct 2016.
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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.
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?
An observational study of Obese, run by Örebro University, Sweden at 1 site in Sweden.
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 3 inclusion and 1 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 7 Oct 2016. 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 Sweden. 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 to intubation seconds (s) (time frame: Up to 1 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 7 Oct 2016.