Intubation ComplicationNCT04365608
Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment
A study testing Direct laryngoscopy and Vie Scope laryngoscopy in people with Intubation Complication and Intubation; Difficult or Failed, run by Lazarski University at 2 sites in Poland.
Trial summary
The safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication, Intubation; Difficult or Failed, Cardiac Arrest
- What is being tested?
- Direct laryngoscopy and Vie Scope laryngoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesPoland
- Study dates
- 20 Mar 2020to 10 Dec 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
- All adult patients requiring out-of-hospital intubation
Who cannot join
- Patient under 18 years old
- Patients with criteria predictive of impossible intubation under direct laryngoscopy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Safety and Efficacy of Endotracheal Intubation by Paramedics in Suspected/Confirmed COVID-19 Patients Under Cardiac Arrest Using Vie Scope Laryngoscope
The safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature. This study will answer whether using a Vie Scope laryngoscope will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.
Read the detailed description
Intubation will be carried out in full personal protective equipment conditions of the operator
- Conditions
- Intubation Complication, Intubation; Difficult or Failed, Cardiac Arrest, Influenza, Safety Issues
- Being tested
- Direct laryngoscopy, Vie Scope laryngoscopy
- Keywords
- endotracheal intubation, cardiac arrest, personal protective equipment, laryngoscope, Vie Scope, COVID-19, SARS-CoV-2, emergency medicine
- Medical subject headings
- Heart Arrest, Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct laryngoscopyProcedure or surgery
Also called MAC
standard laryngoscope with Macintosh blade
Vie Scope laryngoscopyProcedure or surgery
Also called VCE
Vie Scope with dedicated bougie stylet
| Study group | Role | What they receive |
|---|---|---|
| Direct laryngoscopy | Active comparator | Intubation will be done using direct laryngoscopy. The standard intubation procedure is to use a styletted tube and no sedation. When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the guidelines on difficult airway management. Receives: Procedure: Direct laryngoscopy |
| Vie Scope laryngoscopy | Active comparator | Intubation will be done using Vie Scope laryngoscopy Receives: Procedure: Vie Scope laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation success rate during at the first laryngoscopy
Definition of failed intubation: Time to intubation is longer than 120 seconds or wrong placement of endotracheal tube (For example : Esophageal intubation etc.)
Measured: 10 min
Secondary outcomes (6)
Intubation difficulty Scale score
Intubation difficulty assessed by Intubation difficulty Scale score
Measured: 10 min
Complications related to tracheal intubation
Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation
Measured: 10 min
Time to completion of tracheal intubation (TI) procedure
Time to completion of tracheal intubation (TI) procedure measured from the instant that the laryngoscope blade touches the patient to the moment that the tracheal tube cuff is inflated
Measured: 10 min
Duration of the interruption of chest compression during ETI procedure
Duration of the interruption of chest compression during ETI procedure
Measured: 10 min
Laryngeal View during intubation
We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system.
Measured: 10 min
POGO score
self-reported percentage of glottis opening (POGO) score
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start20 Mar 2020
- Primary completion30 Nov 2020
- Study completion10 Dec 2020
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 Intubation ComplicationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Wroclaw Medical University, Medical University of Bialystok
- Responsible party
- Principal investigator, Lukasz Szarpak, Lazarski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365608
- Sponsor's protocol ID
- INT_EMS_PPE_1
- Status last verified
- Dec 2020
- First submitted
- 24 Apr 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Szarpak L, Peacock FW, Rafique Z, Ladny JR, Nadolny K, Malysz M, Dabrowski M, Chirico F, Smereka J. Comparison of Vie Scope(R) and Macintosh laryngoscopes for intubation during resuscitation by paramedics wearing personal protective equipment. Am J Emerg Med. 2022 Mar;53:122-126. doi: 10.1016/j.ajem.2021.12.069. Epub 2022 Jan 4.
PubMed 35016094
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endotracheal Intubation by Paramedics in Suspected/Confirmed COVID-19 Patients Under Cardiac Arrest Using Vie Scope Laryngoscope
- ClinicalTrials.gov ID
- NCT04365608
- Acronym / sponsor ID
- INT_EMS_PPE_1
- Conditions
- Intubation Complication, Intubation; Difficult or Failed, Cardiac Arrest, Influenza, Safety Issues
- Keywords
- endotracheal intubation, cardiac arrest, personal protective equipment, laryngoscope, Vie Scope, COVID-19, SARS-CoV-2, emergency medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Wroclaw Medical University, Medical University of Bialystok
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 28 Apr 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.
The safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature. This study will answer whether using a Vie Scope laryngoscope will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.
Detailed description
Intubation will be carried out in full personal protective equipment conditions of the operator
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct laryngoscopy | Active comparator | Procedure: Direct laryngoscopyIntubation will be done using direct laryngoscopy. The standard intubation procedure is to use a styletted tube and no sedation. When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the guidelines on difficult airway management. |
| Vie Scope laryngoscopy | Active comparator | Procedure: Vie Scope laryngoscopyIntubation will be done using Vie Scope laryngoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients requiring out-of-hospital intubation
Key exclusion criteria (2 listed)
- Patient under 18 years old
- Patients with criteria predictive of impossible intubation under direct laryngoscopy
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 |
|---|---|---|
| Direct laryngoscopyAlso: MACstandard laryngoscope with Macintosh blade | Procedure or surgery | Direct laryngoscopy |
| Vie Scope laryngoscopyAlso: VCEVie Scope with dedicated bougie stylet | Procedure or surgery | Vie Scope laryngoscopy |
Primary outcome
Intubation success rate during at the first laryngoscopy
Time frame: 10 min
Definition of failed intubation: Time to intubation is longer than 120 seconds or wrong placement of endotracheal tube (For example : Esophageal intubation etc.)
6 secondary outcomes
Intubation difficulty Scale score
Time frame: 10 min
Complications related to tracheal intubation
Time frame: 10 min
Time to completion of tracheal intubation (TI) procedure
Time frame: 10 min
Duration of the interruption of chest compression during ETI procedure
Time frame: 10 min
Laryngeal View during intubation
Time frame: 10 min
POGO score
Time frame: 10 min
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 19 Dec 2020.
- Derived from this study: PubMed 35016094Szarpak L, Peacock FW, Rafique Z, Ladny JR, Nadolny K, Malysz M, Dabrowski M, Chirico F, Smereka J. Comparison of Vie Scope(R) and Macintosh laryngoscopes for intubation during resuscitation by paramedics wearing personal protective equipment. Am J Emerg Med. 2022 Mar;53:122-126. doi: 10.1016/j.ajem.2021.12.069. Epub 2022 Jan 4.
- Individual participant dataSharing planned: Yes
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Recruiting
The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct laryngoscopy and Vie Scope laryngoscopy in people with Intubation Complication and Intubation; Difficult or Failed, run by Lazarski University at 2 sites 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 1 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Intubation success rate during at the first laryngoscopy (time frame: 10 min). 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 NCT04365608, 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 19 Dec 2020.