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Pleural Sliding During Valsalva and Muller Maneuvers (VALMUL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02386696
Recruitment Status : Completed
First Posted : March 12, 2015
Last Update Posted : March 24, 2015
Sponsor:
Collaborator:
Daniele Guerino Biasucci, M.D.
Information provided by (Responsible Party):
Franco Cavaliere, Catholic University of the Sacred Heart

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.


Condition or disease Intervention/treatment Phase
Pleural and Lung Ultrasound Other: Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Pleural Sliding and Contraction of Intercostal Muscles: Ultrasound Findings During Valsalva and Muller Maneuvers
Study Start Date : January 2015
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound findings

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
Lung ultrasound examination on healthy volunteers




Primary Outcome Measures :
  1. lung ultrasound artifacts during contraction of the inspiratory and expiratory muscles with closed glottis (Valsalva and Muller maneuvers). [ Time Frame: 16 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386696


Sponsors and Collaborators
Catholic University of the Sacred Heart
Daniele Guerino Biasucci, M.D.
Investigators
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Principal Investigator: Franco Cavaliere, M.D., Prof. Institute of Anesthesia and Intensive Care Medicine, Catholic University of the Sacred Heart in Rome, Italy
Publications:

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Responsible Party: Franco Cavaliere, Franco Cavaliere, M.D., Prof., Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02386696    
Other Study ID Numbers: 1436/15
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015