Intubation, IntratrachealNCT03301324
Intubation Assist Clinical Study
An observational study of Intubation, Intratracheal, run by Zoll Medical Corporation at 1 site in Norway.
Trial summary
The Intubation Assist Clinical Study is an observational study of adult patients scheduled for elective surgery under general anesthesia to assess the user interface, assess transthoracic impedance by the ventilation volume and assess transthoracic impedance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Intubation Assist Dashboard
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteNorway
- Study dates
- 12 Sep 2017to 20 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective surgery using general anesthesia
Who may be able to join
- 18 years of age or older
- Requiring intubation and assisted ventilation
- Patient undergoing elective surgery
- Able to give informed consent
Who cannot join
- Skin condition that would interfere with electrodes
- Inability/failure to intubate
- Pregnancy
- Surgery that prevents the application of electrodes and monitoring equipment.
- Previous excision of complete or partial lung; congenital lung abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
The Intubation Assist Clinical Study is an observational study of adult patients scheduled for elective surgery under general anesthesia to assess the user interface, assess transthoracic impedance by the ventilation volume and assess transthoracic impedance. Monitoring will begin at the time the patient is pre-oxygenated in preparation for endotracheal intubation and will continue until 30 minutes after intubation is achieved.
- Conditions
- Intubation, Intratracheal
- Being tested
- Intubation Assist Dashboard
- Keywords
- intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation Assist DashboardDevice
The ZOLL X Series Intubation Assist Dashboard feature guides the operator through a three-step auscultation process to verify the proper placement of an endotracheal tube.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the user interface
Measured: Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation
Secondary outcomes (1)
Assessment of transthoracic impedance
Measured: Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start12 Sep 2017
- Primary completion20 Sep 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Wik, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301324
- Sponsor's protocol ID
- 7701
- Status last verified
- Jan 2018
- First submitted
- 21 Sep 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kramer-Johansen J, Eilevstjonn J, Olasveengen TM, Tomlinson AE, Dorph E, Steen PA. Transthoracic impedance changes as a tool to detect malpositioned tracheal tubes. Resuscitation. 2008 Jan;76(1):11-6. doi: 10.1016/j.resuscitation.2007.07.021. Epub 2007 Aug 23.
PubMed 17719166Losert H, Risdal M, Sterz F, Nysaether J, Kohler K, Eftestol T, Wandaller C, Myklebust H, Uray T, Sodeck G, Laggner AN. Thoracic impedance changes measured via defibrillator pads can monitor ventilation in critically ill patients and during cardiopulmonary resuscitation. Crit Care Med. 2006 Sep;34(9):2399-405. doi: 10.1097/01.CCM.0000235666.40378.60.
PubMed 16850000Roberts K, Srinivasan V, Niles DE, Eilevstjonn J, Tyler L, Boyle L, Bishnoi R, Ferry S, Nysaether J, Stavland M, Litman RS, Helfaer M, Nadkarni V. Does change in thoracic impedance measured via defibrillator electrode pads accurately detect ventilation breaths in children? Resuscitation. 2010 Nov;81(11):1544-9. doi: 10.1016/j.resuscitation.2010.07.010. Epub 2010 Aug 25.
PubMed 20800333Hamilton LH, Beard JD, Kory RC. Impedance measurement of tidal volume and ventilation. J Appl Physiol. 1965 May;20(3):565-8. doi: 10.1152/jappl.1965.20.3.565. No abstract available.
PubMed 5837579Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
PubMed 15271750Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61. doi: 10.1097/01.CCM.0000233879.58720.87.
PubMed 16850003
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation Assist Clinical Study
- ClinicalTrials.gov ID
- NCT03301324
- Acronym / sponsor ID
- 7701
- Conditions
- Intubation, Intratracheal
- Keywords
- intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 4 Oct 2017 (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 Intubation Assist Clinical Study is an observational study of adult patients scheduled for elective surgery under general anesthesia to assess the user interface, assess transthoracic impedance by the ventilation volume and assess transthoracic impedance. Monitoring will begin at the time the patient is pre-oxygenated in preparation for endotracheal intubation and will continue until 30 minutes after intubation is achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective surgery using general anesthesia
Key inclusion criteria (4 listed)
- 18 years of age or older
- Requiring intubation and assisted ventilation
- Patient undergoing elective surgery
- Able to give informed consent
Key exclusion criteria (5 listed)
- Skin condition that would interfere with electrodes
- Inability/failure to intubate
- Pregnancy
- Surgery that prevents the application of electrodes and monitoring equipment.
- Previous excision of complete or partial lung; congenital lung abnormalities.
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 |
|---|---|---|
| Intubation Assist DashboardThe ZOLL X Series Intubation Assist Dashboard feature guides the operator through a three-step auscultation process to verify the proper placement of an endotracheal tube. | Device | – |
Primary outcome
Assessment of the user interface
Time frame: Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation
1 secondary outcome
Assessment of transthoracic impedance
Time frame: Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation
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 18 Jan 2018.
- Background: PubMed 17719166Kramer-Johansen J, Eilevstjonn J, Olasveengen TM, Tomlinson AE, Dorph E, Steen PA. Transthoracic impedance changes as a tool to detect malpositioned tracheal tubes. Resuscitation. 2008 Jan;76(1):11-6. doi: 10.1016/j.resuscitation.2007.07.021. Epub 2007 Aug 23.
- Background: PubMed 16850000Losert H, Risdal M, Sterz F, Nysaether J, Kohler K, Eftestol T, Wandaller C, Myklebust H, Uray T, Sodeck G, Laggner AN. Thoracic impedance changes measured via defibrillator pads can monitor ventilation in critically ill patients and during cardiopulmonary resuscitation. Crit Care Med. 2006 Sep;34(9):2399-405. doi: 10.1097/01.CCM.0000235666.40378.60.
- Background: PubMed 20800333Roberts K, Srinivasan V, Niles DE, Eilevstjonn J, Tyler L, Boyle L, Bishnoi R, Ferry S, Nysaether J, Stavland M, Litman RS, Helfaer M, Nadkarni V. Does change in thoracic impedance measured via defibrillator electrode pads accurately detect ventilation breaths in children? Resuscitation. 2010 Nov;81(11):1544-9. doi: 10.1016/j.resuscitation.2010.07.010. Epub 2010 Aug 25.
- Background: PubMed 5837579Hamilton LH, Beard JD, Kory RC. Impedance measurement of tidal volume and ventilation. J Appl Physiol. 1965 May;20(3):565-8. doi: 10.1152/jappl.1965.20.3.565. No abstract available.
- Background: PubMed 15271750Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
- Background: PubMed 16850003Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61. doi: 10.1097/01.CCM.0000233879.58720.87.
- Individual participant dataSharing planned: No
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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.
Lars Wik, MD principal investigator
Oslo University Hospital
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 Intubation, Intratracheal, run by Zoll Medical Corporation at 1 site in Norway.
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 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 18 Jan 2018. 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 Norway. 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?
Assessment of the user interface (time frame: Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation). 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 NCT03301324, which also lists 6 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 18 Jan 2018.