COVID-19 PneumoniaNCT05121701
Covid-19 Pandemic and Use of Video Laryngoscopy
A study testing Videolaryngoscope and Macintosh Laryngoscope in people with COVID-19 Pneumonia, run by Van Bölge Eğitim ve Araştırma Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a highly contagious infection with the highest viral load in the upper respiratory secretions. Despite using personal protective equipment, SARS-CoV-2 contamination to the healthcare personnel is possible during the airway management of infected… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Videolaryngoscope and Macintosh Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2021to 1 Mar 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- Elective surgery
Who cannot join
- Intraoral or neck surgery
- gastroesophageal reflux
- delayed gastric emptying
- pregnancy
- scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Airway Management During the Covid-19 Pandemic: A Comparison of Direct Laryngoscopy Versus Video Laryngoscopy
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a highly contagious infection with the highest viral load in the upper respiratory secretions. Despite using personal protective equipment, SARS-CoV-2 contamination to the healthcare personnel is possible during the airway management of infected patients. Direct laryngoscopy remains as the most common method for endotracheal intubation. Our study aimed to compare the use of video laryngoscopy with direct laryngoscopy for tracheal intubation in adult patients receiving general anesthesia for elective surgery during the COVID-19 pandemic.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Videolaryngoscope, Macintosh Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopeDevice
C-MAC PM-Karl Storz
Macintosh LaryngoscopeDevice
Laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscopy | Active comparator | The patients were intubated with the C-MAC PM-Karl Storz Video laryngoscope. Receives: Device: Videolaryngoscope |
| Laryngoscopy | Active comparator | The patients were intubated with the Macintosh laryngoscope. Receives: Device: Macintosh Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Time from Beginning of Intubation to Full Ventilation of the Lungs
Measured: First 5 minutes of the operation
Secondary outcomes (2)
Intubation Comfort
Scale(0=bad, 1=moderate, 2=good 3=very good)
Measured: First 5 minutes of the operation
Cormack-Lehane Scoring
Scale(1= Full view of glottis, 2=Partial view of glottis 3=Only epiglottis seen, none of glottis seen 4=Neither glottis nor epiglottis seen)
Measured: First 5 minutes of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start30 Nov 2021
- Primary completion15 Feb 2022
- Study completion1 Mar 2022
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 COVID-19 PneumoniaStudies 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
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Van Bölge Eğitim ve Araştırma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, sedef gülçin ural, Erzurum Regional Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121701
- Sponsor's protocol ID
- ERZURUMSEHIR1
- Status last verified
- Mar 2022
- First submitted
- 15 Nov 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Piepho T, Fortmueller K, Heid FM, Schmidtmann I, Werner C, Noppens RR. Performance of the C-MAC video laryngoscope in patients after a limited glottic view using Macintosh laryngoscopy. Anaesthesia. 2011 Dec;66(12):1101-5. doi: 10.1111/j.1365-2044.2011.06872.x. Epub 2011 Aug 25.
PubMed 21883131
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management During the Covid-19 Pandemic: A Comparison of Direct Laryngoscopy Versus Video Laryngoscopy
- ClinicalTrials.gov ID
- NCT05121701
- Acronym / sponsor ID
- ERZURUMSEHIR1
- Conditions
- COVID-19 Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Van Bölge Eğitim ve Araştırma HastanesiOther government
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 16 Nov 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.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a highly contagious infection with the highest viral load in the upper respiratory secretions. Despite using personal protective equipment, SARS-CoV-2 contamination to the healthcare personnel is possible during the airway management of infected patients. Direct laryngoscopy remains as the most common method for endotracheal intubation. Our study aimed to compare the use of video laryngoscopy with direct laryngoscopy for tracheal intubation in adult patients receiving general anesthesia for elective surgery during the COVID-19 pandemic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscopy | Active comparator | Device: VideolaryngoscopeThe patients were intubated with the C-MAC PM-Karl Storz Video laryngoscope. |
| Laryngoscopy | Active comparator | Device: Macintosh LaryngoscopeThe patients were intubated with the Macintosh laryngoscope. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- Elective surgery
Key exclusion criteria (5 listed)
- Intraoral or neck surgery
- gastroesophageal reflux
- delayed gastric emptying
- pregnancy
- scoliosis
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 |
|---|---|---|
| VideolaryngoscopeC-MAC PM-Karl Storz | Device | Videolaryngoscopy |
| Macintosh LaryngoscopeLaryngoscope | Device | Laryngoscopy |
Primary outcome
Intubation time
Time frame: First 5 minutes of the operation
Time from Beginning of Intubation to Full Ventilation of the Lungs
2 secondary outcomes
Intubation Comfort
Time frame: First 5 minutes of the operation
Cormack-Lehane Scoring
Time frame: First 5 minutes of the operation
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 9 Mar 2022.
- Background: PubMed 21883131Piepho T, Fortmueller K, Heid FM, Schmidtmann I, Werner C, Noppens RR. Performance of the C-MAC video laryngoscope in patients after a limited glottic view using Macintosh laryngoscopy. Anaesthesia. 2011 Dec;66(12):1101-5. doi: 10.1111/j.1365-2044.2011.06872.x. Epub 2011 Aug 25.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Videolaryngoscope and Macintosh Laryngoscope in people with COVID-19 Pneumonia, run by Van Bölge Eğitim ve Araştırma Hastanesi at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 9 Mar 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 Turkey (Türkiye). 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?
Intubation time (time frame: First 5 minutes of the operation). 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 NCT05121701, 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 9 Mar 2022.