Influence of Xenon Anaesthesia on Transpulmonary Pressure and Tidal Volume Distribution

NCT02682758 | Completed Phase 4

• 1 other identifier: 5161R
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The influence of xenon anaesthesia on transpulmonary pressure and tidal volume distribution will be investigated in a prospective cohort study in 10 patients of normal weight and 10 obese patients undergoing routine xenon-based, general anaesthesia for surgery.

Conditions

Anesthesia

Keywords

xenon; transpulmonary pressure; electrical impedance tomography; tidal volume; esophageal pressure measurement

Outcome Measures

Primary Outcomes (1)

• Change in transpulmonary pressure after Xenon wash-in

  5 minutes before and 5 minutes after xenon-wash in

Secondary Outcomes (1)

• Change in tidal volume Distribution as measured by Electrical impedance tomography

  5 minutes before induction of anaesthesia, 5 minutes before 5 minutes after xenon wash-in

Study Arms (2)

Patients of normal weight

OTHER

Patients undergoing routine xenon-based general anaesthesia for surgery with a body mass index of less than 30.

Drug: Xenon

Obese patients

OTHER

Patients undergoing routine xenon-based general anaesthesia for surgery with a body mass index equal to or more than 30.

Drug: Xenon

Interventions

Xenon DRUG

Wash-in of xenon for maintenance of anaesthesia

Also known as: Xenon pro Anaesthesia

Obese patients; Patients of normal weight

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Xenon-based, general anaesthesia for elective surgery independent of this investigation

You may not qualify if:

• Inability to provide informed consent
• Known pregnancy
• American Society of Anesthesiologists status \>III
• Restrictive or obstructive pulmonary disease
• History of esophageal or gastric operation
• Esophageal varices
• Liver cirrhosis Child-Pugh B or C
• Therapeutic anticoagulation
• Cardiac pacemaker or internal automatic defibrillator

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Department of Anesthesiology, Düsseldorf University Hospital

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (3)

• Frerichs I, Dargaville PA, van Genderingen H, Morel DR, Rimensberger PC. Lung volume recruitment after surfactant administration modifies spatial distribution of ventilation. Am J Respir Crit Care Med. 2006 Oct 1;174(7):772-9. doi: 10.1164/rccm.200512-1942OC. Epub 2006 Jul 13.

  PMID: 16840739 BACKGROUND

• Zhao Z, Moller K, Steinmann D, Frerichs I, Guttmann J. Evaluation of an electrical impedance tomography-based Global Inhomogeneity Index for pulmonary ventilation distribution. Intensive Care Med. 2009 Nov;35(11):1900-6. doi: 10.1007/s00134-009-1589-y. Epub 2009 Aug 4.

  PMID: 19652949 BACKGROUND

• Schaefer MS, Treschan TA, Gauch J, Neukirchen M, Kienbaum P. Influence of xenon on pulmonary mechanics and lung aeration in patients with healthy lungs. Br J Anaesth. 2018 Jun;120(6):1394-1400. doi: 10.1016/j.bja.2018.02.064. Epub 2018 Apr 13.

  PMID: 29793604 DERIVED

MeSH Terms

Interventions

Xenon

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Peter Kienbaum, MD

  Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 15, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

DE (1)