Intubation;DifficultNCT04959149
Face-to-face Intubation in Morbidly Obese
A study testing AirTraq videolaryngoscope in people with Intubation;Difficult and Obesity, Morbid, run by Medical University of Lodz at 1 site in Poland.
Trial summary
Introduction : In a typical endotracheal intubation, the patient is in the supine position, with the anesthetist standing behind his head and with adequate access to the head and neck of the patient. However, there are several situations, where traditional intubation is very difficult or even impossible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation;Difficult, Obesity, Morbid
- What is being tested?
- AirTraq videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2020to 30 Sep 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 40 kg.m-2
- Patients qualified for planned sleeve gastrectomy.
- Patients of I and II class of ASA scale.
- Patients without history of difficult intubation.
Who cannot join
- Patients in life threatening states.
- Patients of III, IV, V and VI class of ASA scale.
- History of difficult intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Face-to-face Endotracheal Intubation and Typical Intubation With Airtraq Video Laryngoscope in Bariatric Patients: a Randomised Controlled Trail
Introduction : In a typical endotracheal intubation, the patient is in the supine position, with the anesthetist standing behind his head and with adequate access to the head and neck of the patient. However, there are several situations, where traditional intubation is very difficult or even impossible. In immobilised trauma victims, with limited access to the head, suspected cervical spine injury or in sitting positioned patient an intubation performed by a person standing in front of a patient might be the only chance of airway management. Moreover, in case of general anesthesia in bariatric patients, face-to-face (inverse) method is increasingly being considered due to upper body elevation position, recommended in this group of patients.
This was a parallel randomised controlled trial in patients scheduled for planned sleeve gastrectomy in Barlicki University Hospital, Lodz, Poland. Randomization and allocation to trial group were carried out by drawing envelopes by independent observer before a procedure. Randomized and recruited participants were 76 adults (typical intubation n= 36, face-to-face intubation n=40). Main outcome was a time of intubation using Airtraq video laryngoscope measured by independent assistant.
Read the detailed description
Aim : The aim of the study is to evaluate the effectiveness and safety of face-to-face intubation in airway management.
Methods : Patients admitted to hospital for elective sleeve gastrectomy procedure will be included in the study protocol. Before induction of anaesthesia the draw of the method will be held. The choice of method of intubation (inverse or typical) will be random.
- All patients will be positioned with the elevation of the upper body about 30 degrees. The standard anesthesia monitoring involves electrocardiogram, pulsoxymetry, non-invasive blood pressure and end-tidal carbon dioxide.
- Patients will be pre-oxygenated for 5 min. with 100% oxygen using facemask.
- The induction of general anesthesia will be performed by the intravenous administration of 1-2 µg.kg-1 of fentanyl and 2-2,5 mg.kg-1 propofol.
- After mask ventilation possibility is confirmed, rocuronium in a dose of 0,6 mg.kg-1 will be given.
- After obtaining an optimal muscle relaxation (90 s.) patient will be intubated. In face-to-face method an anesthetist is standing in front of a patient. In typical intubation an anesthetist is standing behind the patient's head.
- In case of prolonged face-to-face intubation (>120 s) or 2 unsuccessful attempts, patients are supposed to be intubated in a traditional way with the same video laryngoscope.
- General anesthesia will be continued with desflurane and a mixture of the oxygen and air, volume-controlled ventilation parameters will be adjusted to age and ideal body weight.
- Conditions
- Intubation;Difficult, Obesity, Morbid
- Being tested
- AirTraq videolaryngoscope
- Keywords
- obesity, intubation, videolaryngoscope
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirTraq videolaryngoscopeDevice
intubation of morbidly obese patient using Airtraq videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| face-to-face intubation | Experimental | intubation approach from front of the patient Receives: Device: AirTraq videolaryngoscope |
| standard position intubation | Active comparator | intubation approach from behind the head of the patient Receives: Device: AirTraq videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of intubation
time of intubation measured from grabbing the device to confirming the correct placement using EtCO2
Measured: during the intervention/procedure
Secondary outcomes (1)
effectiveness
effectiveness as number of correct placement of endotracheal tube in the trachea of the patient
Measured: during the intervention/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Mar 2020
- Primary completion1 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Gaszynski, Medical University of Lodz
- Investigators
- Tomasz Gaszynski, Principal investigator, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959149
- Sponsor's protocol ID
- RNN/62/20/KE
- Status last verified
- Jun 2022
- First submitted
- 28 Dec 2020
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: on request
Publications
Arslan ZI, Alparslan V, Ozdal P, Toker K, Solak M. Face-to-face tracheal intubation in adult patients: a comparison of the Airtraq, Glidescope and Fastrach devices. J Anesth. 2015 Dec;29(6):893-8. doi: 10.1007/s00540-015-2052-6. Epub 2015 Jul 29.
PubMed 26219732Jeong H, Chae M, Seo H, Yi JW, Kang JM, Lee BJ. Face-to-face intubation using a lightwand in a patient with severe thoracolumbar kyphosis: a case report. BMC Anesthesiol. 2018 Jul 21;18(1):92. doi: 10.1186/s12871-018-0556-y.
PubMed 30031381
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Face-to-face Endotracheal Intubation and Typical Intubation With Airtraq Video Laryngoscope in Bariatric Patients: a Randomised Controlled Trail
- ClinicalTrials.gov ID
- NCT04959149
- Acronym / sponsor ID
- RNN/62/20/KE
- Conditions
- Intubation;Difficult, Obesity, Morbid
- Keywords
- obesity, intubation, videolaryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 13 Jul 2021 (actual)
- 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.
Introduction : In a typical endotracheal intubation, the patient is in the supine position, with the anesthetist standing behind his head and with adequate access to the head and neck of the patient. However, there are several situations, where traditional intubation is very difficult or even impossible. In immobilised trauma victims, with limited access to the head, suspected cervical spine injury or in sitting positioned patient an intubation performed by a person standing in front of a patient might be the only chance of airway management. Moreover, in case of general anesthesia in bariatric patients, face-to-face (inverse) method is increasingly being considered due to upper body elevation position, recommended in this group of patients.
This was a parallel randomised controlled trial in patients scheduled for planned sleeve gastrectomy in Barlicki University Hospital, Lodz, Poland. Randomization and allocation to trial group were carried out by drawing envelopes by independent observer before a procedure. Randomized and recruited participants were 76 adults (typical intubation n= 36, face-to-face intubation n=40). Main outcome was a time of intubation using Airtraq video laryngoscope measured by independent assistant.
Detailed description
Aim : The aim of the study is to evaluate the effectiveness and safety of face-to-face intubation in airway management.
Methods : Patients admitted to hospital for elective sleeve gastrectomy procedure will be included in the study protocol. Before induction of anaesthesia the draw of the method will be held. The choice of method of intubation (inverse or typical) will be random.
- All patients will be positioned with the elevation of the upper body about 30 degrees. The standard anesthesia monitoring involves electrocardiogram, pulsoxymetry, non-invasive blood pressure and end-tidal carbon dioxide.
- Patients will be pre-oxygenated for 5 min. with 100% oxygen using facemask.
- The induction of general anesthesia will be performed by the intravenous administration of 1-2 µg.kg-1 of fentanyl and 2-2,5 mg.kg-1 propofol.
- After mask ventilation possibility is confirmed, rocuronium in a dose of 0,6 mg.kg-1 will be given.
- After obtaining an optimal muscle relaxation (90 s.) patient will be intubated. In face-to-face method an anesthetist is standing in front of a patient. In typical intubation an anesthetist is standing behind the patient's head.
- In case of prolonged face-to-face intubation (>120 s) or 2 unsuccessful attempts, patients are supposed to be intubated in a traditional way with the same video laryngoscope.
- General anesthesia will be continued with desflurane and a mixture of the oxygen and air, volume-controlled ventilation parameters will be adjusted to age and ideal body weight.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| face-to-face intubation | Experimental | Device: AirTraq videolaryngoscopeintubation approach from front of the patient |
| standard position intubation | Active comparator | Device: AirTraq videolaryngoscopeintubation approach from behind the head of the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI > 40 kg.m-2
- Patients qualified for planned sleeve gastrectomy.
- Patients of I and II class of ASA scale.
- Patients without history of difficult intubation.
Key exclusion criteria (3 listed)
- Patients in life threatening states.
- Patients of III, IV, V and VI class of ASA scale.
- History of difficult intubation.
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 |
|---|---|---|
| AirTraq videolaryngoscopeintubation of morbidly obese patient using Airtraq videolaryngoscope | Device | face-to-face intubation, standard position intubation |
Primary outcome
time of intubation
Time frame: during the intervention/procedure
time of intubation measured from grabbing the device to confirming the correct placement using EtCO2
1 secondary outcome
effectiveness
Time frame: during the intervention/procedure
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 10 Jun 2022.
- Background: PubMed 26219732Arslan ZI, Alparslan V, Ozdal P, Toker K, Solak M. Face-to-face tracheal intubation in adult patients: a comparison of the Airtraq, Glidescope and Fastrach devices. J Anesth. 2015 Dec;29(6):893-8. doi: 10.1007/s00540-015-2052-6. Epub 2015 Jul 29.
- Background: PubMed 30031381Jeong H, Chae M, Seo H, Yi JW, Kang JM, Lee BJ. Face-to-face intubation using a lightwand in a patient with severe thoracolumbar kyphosis: a case report. BMC Anesthesiol. 2018 Jul 21;18(1):92. doi: 10.1186/s12871-018-0556-y.
- Individual participant dataSharing planned: No. on request
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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.
Tomasz Gaszynski principal investigator
Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirTraq videolaryngoscope in people with Intubation;Difficult and Obesity, Morbid, run by Medical University of Lodz at 1 site in Poland.
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 3 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 10 Jun 2022. 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 Poland. 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 intubation (time frame: during the intervention/procedure). 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 NCT04959149, which also lists 2 linked publications.
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 10 Jun 2022.