NCT02386696

Brief Summary

Recently, ultrasound artifacts mimicking lung sliding have been described in absence of the visceral pleura, in a group of patients who underwent pneumonectomy. In these patients, lung sliding was clearly absent during mechanical ventilation in the operated hemithorax. During spontaneous breathing, although of lower intensity compared to the unoperated hemithorax, some artifacts mimicking lung sliding and seashore sign were found during each deep spontaneous breath. These findings have led to the hypothesis that these artifacts may be due to the contraction of the intercostal muscles. The objective of the present study is to reproduce such artifacts during contraction of the inspiratory and expiratory muscles with closed glottis (Valsalva and Muller maneuvers): in this condition each subject is not ventilating and the two pleural layers are not sliding one over each other.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

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

January 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

March 7, 2015

Last Update Submit

March 23, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • lung ultrasound artifacts during contraction of the inspiratory and expiratory muscles with closed glottis (Valsalva and Muller maneuvers).

    16 days

Study Arms (1)

Ultrasound findings

EXPERIMENTAL

Thoracic ultrasound examinations in the following conditions: 1. Apnea; 2. Spontaneous regular breathing; 3. Valsalva maneuver, during which each subject will be asked for performing three forced expirations with closed glottis after one forced inspiration; 4. Muller maneuver, during which each subject will be asked for performing three forced inspirations after one forced expiration; 5. Hyperventilation.

Other: Ultrasound

Interventions

Lung ultrasound examination on healthy volunteers

Ultrasound findings

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Twenty healthy male volunteers aged between 18 and 65 years-old with no history of respiratory or cardiovascular pathologies will be enrolled.

You may not qualify if:

  • Females and all subjects with history of respiratory or cardiovascular diseases will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

    PMID: 22392031BACKGROUND
  • Lichtenstein DA, Menu Y. A bedside ultrasound sign ruling out pneumothorax in the critically ill. Lung sliding. Chest. 1995 Nov;108(5):1345-8. doi: 10.1378/chest.108.5.1345.

    PMID: 7587439BACKGROUND
  • Lichtenstein DA. Ultrasound in the management of thoracic disease. Crit Care Med. 2007 May;35(5 Suppl):S250-61. doi: 10.1097/01.CCM.0000260674.60761.85.

    PMID: 17446785BACKGROUND
  • Koenig SJ, Narasimhan M, Mayo PH. Thoracic ultrasonography for the pulmonary specialist. Chest. 2011 Nov;140(5):1332-1341. doi: 10.1378/chest.11-0348.

    PMID: 22045878BACKGROUND
  • Turner JP, Dankoff J. Thoracic ultrasound. Emerg Med Clin North Am. 2012 May;30(2):451-73, ix. doi: 10.1016/j.emc.2011.12.003.

    PMID: 22487114BACKGROUND
  • Lichtenstein DA, Meziere G, Lascols N, Biderman P, Courret JP, Gepner A, Goldstein I, Tenoudji-Cohen M. Ultrasound diagnosis of occult pneumothorax. Crit Care Med. 2005 Jun;33(6):1231-8. doi: 10.1097/01.ccm.0000164542.86954.b4.

    PMID: 15942336BACKGROUND
  • Alrajhi K, Woo MY, Vaillancourt C. Test characteristics of ultrasonography for the detection of pneumothorax: a systematic review and meta-analysis. Chest. 2012 Mar;141(3):703-708. doi: 10.1378/chest.11-0131. Epub 2011 Aug 25.

    PMID: 21868468BACKGROUND
  • Blaivas M, Lyon M, Duggal S. A prospective comparison of supine chest radiography and bedside ultrasound for the diagnosis of traumatic pneumothorax. Acad Emerg Med. 2005 Sep;12(9):844-9. doi: 10.1197/j.aem.2005.05.005.

    PMID: 16141018BACKGROUND
  • Weaver B, Lyon M, Blaivas M. Confirmation of endotracheal tube placement after intubation using the ultrasound sliding lung sign. Acad Emerg Med. 2006 Mar;13(3):239-44. doi: 10.1197/j.aem.2005.08.014. Epub 2006 Feb 22.

    PMID: 16495415BACKGROUND
  • Cavaliere F, Zamparelli R, Soave MP, Gargaruti R, Scapigliati A, De Paulis S. Ultrasound artifacts mimicking pleural sliding after pneumonectomy. J Clin Anesth. 2014 Mar;26(2):131-5. doi: 10.1016/j.jclinane.2013.09.011. Epub 2014 Feb 21.

    PMID: 24561105BACKGROUND
  • Biasucci DG, Cina A, Sandroni C, Moscato U, Dauri M, Vetrugno L, Cavaliere F. Influence of intercostal muscles contraction on sonographic evaluation of lung sliding: a physiological study on healthy subjects. J Anesth Analg Crit Care. 2024 May 6;4(1):31. doi: 10.1186/s44158-024-00168-0.

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Franco Cavaliere, M.D., Prof.

    Institute of Anesthesia and Intensive Care Medicine, Catholic University of the Sacred Heart in Rome, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Franco Cavaliere, M.D., Prof.

Study Record Dates

First Submitted

March 7, 2015

First Posted

March 12, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 24, 2015

Record last verified: 2015-03