NCT03301324

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2017

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

8 days

First QC Date

September 21, 2017

Last Update Submit

January 16, 2018

Conditions

Intubation, Intratracheal

Keywords

intubation

Outcome Measures

Primary Outcomes (1)

  • Assessment of the user interface

    Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation

Secondary Outcomes (1)

  • Assessment of transthoracic impedance

    Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients scheduled for elective surgery using general anesthesia

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (6)

  • 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.

    PMID: 17719166BACKGROUND

  • 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.

    PMID: 16850000BACKGROUND

  • 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.

    PMID: 20800333BACKGROUND

  • 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.

    PMID: 5837579BACKGROUND

  • 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.

    PMID: 15271750BACKGROUND

  • 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.

    PMID: 16850003BACKGROUND

Study Officials

  • Lars Wik, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2017

First Posted

October 4, 2017

Study Start

September 12, 2017

Primary Completion

September 20, 2017

Study Completion

September 20, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)