Intubation Assist Clinical Study

Intubation, Intratracheal Clinical Trial

Official title:

Intubation Assist Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301324
• Other study ID #: 7701
• Status: Completed
• Phase: N/A
• First received: September 21, 2017
• Last updated: January 16, 2018
• Start date: September 12, 2017
• Est. completion date: September 20, 2017

Study information

• Verified date: January 2018
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 20, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

Norway, 

References & Publications (6)

Hamilton LH, Beard JD, Kory RC. Impedance measurement of tidal volume and ventilation. J Appl Physiol. 1965 May;20(3):565-8. — View Citation

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. — View Citation

Kramer-Johansen J, Eilevstjønn 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. Epub 2007 Aug 23. — View Citation

Losert H, Risdal M, Sterz F, Nysaether J, Köhler K, Eftestøl 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. — View Citation

Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. — View Citation

Roberts K, Srinivasan V, Niles DE, Eilevstjønn 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the user interface		Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation
Secondary	Assessment of transthoracic impedance		Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation