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The Relationship Between Trans-diaphragmatic Pressure and Diaphragmatic Contraction

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03802383
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Information provided by (Responsible Party):
DEMOSTHENES MAKRIS, University of Thessaly

Brief Summary:
Through this study the investigators aim to clarify the relationship between trans-diaphragmatic pressure and various parameters of the diaphragmatic contraction evaluated by ultrasound. The following parameters will be studied: esophageal pressure, gastric pressure, diaphragm thickness at peak inspiration (Tdi,pi), diaphragm thickness at end expiration (Tdi,ee), diaphragm thickening (Tdi,pi - Tdi,ee), diaphragm thickness fraction [TFdi=(Tdi,pi - Tdi,ee)/Tdi,ee], diaphragm excursion (Di,e), Maximal Inspiratory pressure (M.I.P), Pressure-Time product of the trans-diaphragmatic pressure (PΤPdi),Tension Time Diaphragm Index (T.T.Di) and the rapid shallow breathing index (R.S.B.I.). These measurements will be made in two phases.Firstly, during the spontaneous breathing trial and secondly during spontaneous breathing through an airway of reduced diameter.Furthermore, during the M.I.P. test the aforementioned ultrasound parameters will be measured. The aim of this study is to discover new means of a successful prediction of weaning in the first 48 hours following extubation.

Condition or disease
Weaning Failure Respiratory Paralysis Respiratory Failure

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study on the Relationship Between the Trans-diaphragmatic Pressure and the Contraction of the Diaphragm
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : July 30, 2021

Primary Outcome Measures :
  1. The correlation of inspiratory esophageal pressure, as assessed by esophageal manometry, to diaphragmatic thickness, as assessed by ultrasound, in patients who are weaned from mechanical ventilation. [ Time Frame: 1 year ]
    The authors will study the correlation of inspiratory esophageal pressure, as assessed by esophageal manometry (values in cm H2O), to diaphragmatic thickness, as assessed by ultrasound (values in cm), in patients who are weaned from mechanical ventilation.Then a comparison will be made between the patients who failed and those who succeeded. Ten consecutive tidal breaths will be studied both by esophageal manometry and ultrasound of the diaphragm in each patient.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in the Intensive Care Unit of the University Hospital of Larissa

Inclusion Criteria:

Patients meeting the following standards.

  • Respiratory Criteria

    • PaO2≥ 60mmHg with Fraction of Inspired Oxygen (FiO2) ≤ 40-50% & Positive End Expiratory Pressure (PEEP) ≤ 5-8 cm H2O
    • PaCO2 normal or at the level of reference (allowed hypercapnia is allowed)
    • Patient is able to start ventilatory effort
  • Cardiovascular Criteria

    • Absence of myocardial ischemia
    • Heart Rate ≤140 bpm
    • Arterial Pressure normal without vasoconstriction or with minimum vasoconstriction support
  • Adequate level of consciousness

    o Glasgow Coma Scale (GCS ≥ 13)

  • Absence of other reversible comorbidities

    • Afebrile Patient
    • Without important electrolyte disorders

Exclusion Criteria:

  • Obese patients with B.M.I. >35
  • pregnant women
  • patients <18 years old

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 identifier (NCT number): NCT03802383

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Contact: Demosthenes Makris +306943706079

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Critical Care Unit Recruiting
Larissa, Thessaly, Greece
Contact: Dimosthenis Makris         
Sponsors and Collaborators
University of Thessaly
Brochard L. (1991) Transdiaphragmatic Pressure. In: Benito S., Net A. (eds) Pulmonary Function in Mechanically Ventilated Patients. Update in Intensive Care and Emergency Medicine, vol 13. Springer, Berlin, Heidelberg

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Responsible Party: DEMOSTHENES MAKRIS, Associate Professor of Critical Care Medicine, University of Thessaly Identifier: NCT03802383    
Other Study ID Numbers: 3531/29.06.2018
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Paralysis
Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
Nervous System Diseases