Intubation;DifficultNCT04477148
Comparison of Intubation Success Rates of 3 Different Laryngoscope Blade Types in Morbidly Obese Patients
A study testing endotracheal intubation in people with Intubation;Difficult and Morbid Obesity, run by Turkish Society of Anesthesiology and Reanimation.
Trial summary
Reusable laryngoscope blades, which are the most commonly used devices for airway management, have been reported to be frequently contaminated and a possible source of infection. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation;Difficult, Morbid Obesity
- What is being tested?
- endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2014to 26 Jun 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- morbidly obese patients with 18-60 years age
Who cannot join
- less than 3 cm of mouth opening
- airway pathology
- restricted head and neck movement
- expected difficult airway
- sore throat
- upper airway infection
About this study
Official title: Comparison of Intubation Success Rates of Metallic Reusable Laryngoscope Blades and Metallic/Plastic Laryngoscope Blades in Morbidly Obese Patients
Reusable laryngoscope blades, which are the most commonly used devices for airway management, have been reported to be frequently contaminated and a possible source of infection. Although disposable laryngoscope blades are recommended to reduce the risk of infection, there are studies suggesting increased failed intubation attempt rates.
The major cause of anesthesia-related mortality and morbidity is the failure of airway management. The incidence of difficult airway is reported to be 1-4% in normal population while it ranges up to 12-20% in obese patients. Following the introduction of disposable blades and considering the increased rate of failed intubation in obese patients with these devices, the investigators aimed to make a comparison of successful intubation rates of plastic and metallic disposable blades in morbidly obese patients
Read the detailed description
Successful airway management is the first and most important step of patient safety in anesthesia practice, and most common reason of morbidity and mortality related to anesthesia is failure to provide optimum airway safety.
Intubation helps the anesthesiologist have complete control over airway by keeping airway open, facilitating control over ventilation, reducing the risk of aspiration and providing safe airway during resuscitation, and laryngoscopes are most commonly used tools for this purpose. Laryngoscope are comprised of a handle and a blade (also contains light source) which are mostly reusable. But these parts are easily contaminated during intubation, creating susceptibility to infection. Some studies report that even handles have a chance of 50% to be contaminated with blood. Insufficiently disinfected blades are also a major source of infection. Laryngoscopes contact with non-intact mucous membranes and blood frequently, thus play an important role in cross contamination. Abramson et al. reported that 1/3 of reusable laryngoscope blades are contaminated with bacteria after multiple uses. Concerns about hygiene and risk of infection (including prion infections) caused many health professionals tend towards use of disposable medical devices. Following their introduction, single use laryngoscope blades have been subject to many studies, and many opinions were discussed in different platforms. In studies in which intubation success rates of metallic reusable, metallic disposable and plastic disposable blades were compared, while some have demonstratedd their success rates to be identical, others concluded that plastic disposable blades were ineffective compared to two other.
Laryngoscopy and endotracheal intubation may not be easily performed in every case. Airway management and endotracheal intubation are easier in non-obese patients compared to obese patients. Short and relatively immobile neck, narrow interincisor distance, hypertrophic tonsillae, uvula and adenoids in obese patients makes intubation more difficult in these patients. Additionally, loss of muscle tonus causes tongue to obstruct airway and epiglottis to touch posterior wall of pharynx, thus obstructing airway further.
The investigators couldn't find any study conducted on obese patients evaluating success rates for intubation of metallic reusable, metallic disposable and plastic disposable blades in the literature. In this study, they aimed to compare intubation success rates of metallic reusable, metallic disposable and plastic disposable blades in intubation of obese patients.
- Conditions
- Intubation;Difficult, Morbid Obesity
- Being tested
- endotracheal intubation
- Keywords
- Intubation, obesity, disposable blade
- 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.
endotracheal intubationDevice
patients were intubated with 3 different blades
| Study group | Role | What they receive |
|---|---|---|
| Metallic Reusable(MR) | Active comparator | Patients in this group were intubated with reusable metallic blades Receives: Device: endotracheal intubation |
| Metallic Disposable(MD) | Active comparator | Patients in this group were intubated with disposable metallic blades Receives: Device: endotracheal intubation |
| Plastic Disposable(PD) | Active comparator | Patients in this group were intubated with disposable plastic blades Receives: Device: endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison success rate of intubation in three different blades
The investigators compared reusable metal, single-use metal and single-use plastic blades for their effectiveness in laryngoscopy and intubation in morbid obese patients.
Measured: 3 minutes after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start26 Jun 2014
- Primary completion26 Apr 2015
- Study completion26 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Anesthesiology and Reanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477148
- Sponsor's protocol ID
- Uludaguni
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intubation Success Rates of Metallic Reusable Laryngoscope Blades and Metallic/Plastic Laryngoscope Blades in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT04477148
- Acronym / sponsor ID
- Uludaguni
- Conditions
- Intubation;Difficult, Morbid Obesity
- Keywords
- Intubation, obesity, disposable blade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Turkish Society of Anesthesiology and ReanimationUniversity, hospital or other
- Study start
- 26 Jun 2014 (actual)
- Primary completion
- 26 Apr 2015 (actual)
- Study completion
- 26 Jun 2015 (actual)
- First posted
- 20 Jul 2020 (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.
Reusable laryngoscope blades, which are the most commonly used devices for airway management, have been reported to be frequently contaminated and a possible source of infection. Although disposable laryngoscope blades are recommended to reduce the risk of infection, there are studies suggesting increased failed intubation attempt rates.
The major cause of anesthesia-related mortality and morbidity is the failure of airway management. The incidence of difficult airway is reported to be 1-4% in normal population while it ranges up to 12-20% in obese patients. Following the introduction of disposable blades and considering the increased rate of failed intubation in obese patients with these devices, the investigators aimed to make a comparison of successful intubation rates of plastic and metallic disposable blades in morbidly obese patients
Detailed description
Successful airway management is the first and most important step of patient safety in anesthesia practice, and most common reason of morbidity and mortality related to anesthesia is failure to provide optimum airway safety.
Intubation helps the anesthesiologist have complete control over airway by keeping airway open, facilitating control over ventilation, reducing the risk of aspiration and providing safe airway during resuscitation, and laryngoscopes are most commonly used tools for this purpose. Laryngoscope are comprised of a handle and a blade (also contains light source) which are mostly reusable. But these parts are easily contaminated during intubation, creating susceptibility to infection. Some studies report that even handles have a chance of 50% to be contaminated with blood. Insufficiently disinfected blades are also a major source of infection. Laryngoscopes contact with non-intact mucous membranes and blood frequently, thus play an important role in cross contamination. Abramson et al. reported that 1/3 of reusable laryngoscope blades are contaminated with bacteria after multiple uses. Concerns about hygiene and risk of infection (including prion infections) caused many health professionals tend towards use of disposable medical devices. Following their introduction, single use laryngoscope blades have been subject to many studies, and many opinions were discussed in different platforms. In studies in which intubation success rates of metallic reusable, metallic disposable and plastic disposable blades were compared, while some have demonstratedd their success rates to be identical, others concluded that plastic disposable blades were ineffective compared to two other.
Laryngoscopy and endotracheal intubation may not be easily performed in every case. Airway management and endotracheal intubation are easier in non-obese patients compared to obese patients. Short and relatively immobile neck, narrow interincisor distance, hypertrophic tonsillae, uvula and adenoids in obese patients makes intubation more difficult in these patients. Additionally, loss of muscle tonus causes tongue to obstruct airway and epiglottis to touch posterior wall of pharynx, thus obstructing airway further.
The investigators couldn't find any study conducted on obese patients evaluating success rates for intubation of metallic reusable, metallic disposable and plastic disposable blades in the literature. In this study, they aimed to compare intubation success rates of metallic reusable, metallic disposable and plastic disposable blades in intubation of obese patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metallic Reusable(MR) | Active comparator | Device: endotracheal intubationPatients in this group were intubated with reusable metallic blades |
| Metallic Disposable(MD) | Active comparator | Device: endotracheal intubationPatients in this group were intubated with disposable metallic blades |
| Plastic Disposable(PD) | Active comparator | Device: endotracheal intubationPatients in this group were intubated with disposable plastic blades |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- morbidly obese patients with 18-60 years age
Key exclusion criteria (6 listed)
- less than 3 cm of mouth opening
- airway pathology
- restricted head and neck movement
- expected difficult airway
- sore throat
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 |
|---|---|---|
| endotracheal intubationpatients were intubated with 3 different blades | Device | Metallic Disposable(MD), Metallic Reusable(MR), Plastic Disposable(PD) |
Primary outcome
comparison success rate of intubation in three different blades
Time frame: 3 minutes after anesthesia induction
The investigators compared reusable metal, single-use metal and single-use plastic blades for their effectiveness in laryngoscopy and intubation in morbid obese patients.
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 20 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Intubation;Difficult
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
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.
Questions about this trial
What is this clinical trial studying?
A study testing endotracheal intubation in people with Intubation;Difficult and Morbid Obesity, run by Turkish Society of Anesthesiology and Reanimation.
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 6 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 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
comparison success rate of intubation in three different blades (time frame: 3 minutes after anesthesia induction). 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 20 Jul 2020.