Intubation Assist Clinical Study

NCT ID: NCT03301324

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-12

Study Completion Date

2017-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Intubation, Intratracheal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Intubation Assist Dashboard

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Requiring intubation and assisted ventilation
* Patient undergoing elective surgery
* Able to give informed consent

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Wik, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 17719166 (View on PubMed)

Losert 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.

Reference Type BACKGROUND
PMID: 16850000 (View on PubMed)

Roberts 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.

Reference Type BACKGROUND
PMID: 20800333 (View on PubMed)

Hamilton 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.

Reference Type BACKGROUND
PMID: 5837579 (View on PubMed)

Mort 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.

Reference Type BACKGROUND
PMID: 15271750 (View on PubMed)

Jaber 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.

Reference Type BACKGROUND
PMID: 16850003 (View on PubMed)

Other Identifiers

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7701

Identifier Type: -

Identifier Source: org_study_id

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