The Relationship Between Trans-diaphragmatic Pressure and Diaphragmatic Contraction

NCT03802383 | Recruiting

• 1 other identifier: 3531/29.06.2018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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. Moreover, a lung ultrasound exam will be performed at the end of spontaneous breathing, resistive breathing and maximal inspiratory pressure maneuver (MIP) in order to assess with the use of B-lines for extravascular lung water (EVLW). 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 (Dec), Maximal Inspiratory pressure (M.I.P), Pressure-Time product of the esophageal pressure (PΤPes),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.

Conditions

Weaning Failure; Respiratory Paralysis; Respiratory Failure

Outcome Measures

Primary Outcomes (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.

  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.

  1 year

Eligibility Criteria

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

Study Population

Patients in the Intensive Care Unit of the University Hospital of Larissa

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Critical Care Unit

Larissa, Thessaly, Greece

RECRUITING

Related Publications (15)

• 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

  BACKGROUND

• Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.

  PMID: 27334266 BACKGROUND

• Turnbull D, Webber S, Hamnegard CH, Mills GH. Intra-abdominal pressure measurement: validation of intragastric pressure as a measure of intra-abdominal pressure. Br J Anaesth. 2007 May;98(5):628-34. doi: 10.1093/bja/aem060.

  PMID: 17456490 BACKGROUND

• Beaulieu Y, Marik PE. Bedside ultrasonography in the ICU: part 1. Chest. 2005 Aug;128(2):881-95. doi: 10.1378/chest.128.2.881.

  PMID: 16100182 BACKGROUND

• Beaulieu Y, Marik PE. Bedside ultrasonography in the ICU: part 2. Chest. 2005 Sep;128(3):1766-81. doi: 10.1378/chest.128.3.1766.

  PMID: 16162786 BACKGROUND

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Goligher EC, Laghi F, Detsky ME, Farias P, Murray A, Brace D, Brochard LJ, Bolz SS, Rubenfeld GD, Kavanagh BP, Ferguson ND. Measuring diaphragm thickness with ultrasound in mechanically ventilated patients: feasibility, reproducibility and validity. Intensive Care Med. 2015 Apr;41(4):734. doi: 10.1007/s00134-015-3724-2. No abstract available.

  PMID: 25749574 BACKGROUND

• MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.

  PMID: 11742959 BACKGROUND

• MILIC-EMILI J, MEAD J, TURNER JM, GLAUSER EM. IMPROVED TECHNIQUE FOR ESTIMATING PLEURAL PRESSURE FROM ESOPHAGEAL BALLOONS. J Appl Physiol. 1964 Mar;19:207-11. doi: 10.1152/jappl.1964.19.2.207. No abstract available.

  PMID: 14155283 BACKGROUND

• Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.

  PMID: 7149443 BACKGROUND

• Bellemare F, Grassino A. Effect of pressure and timing of contraction on human diaphragm fatigue. J Appl Physiol Respir Environ Exerc Physiol. 1982 Nov;53(5):1190-5. doi: 10.1152/jappl.1982.53.5.1190.

  PMID: 7174413 BACKGROUND

• Grinnan DC, Truwit JD. Clinical review: respiratory mechanics in spontaneous and assisted ventilation. Crit Care. 2005 Oct 5;9(5):472-84. doi: 10.1186/cc3516. Epub 2005 Apr 18.

  PMID: 16277736 BACKGROUND

• Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.

  PMID: 22476448 BACKGROUND

• Yang KL, Tobin MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med. 1991 May 23;324(21):1445-50. doi: 10.1056/NEJM199105233242101.

  PMID: 2023603 BACKGROUND

• Nemer SN, Barbas CS, Caldeira JB, Guimaraes B, Azeredo LM, Gago R, Souza PC. Evaluation of maximal inspiratory pressure, tracheal airway occlusion pressure, and its ratio in the weaning outcome. J Crit Care. 2009 Sep;24(3):441-6. doi: 10.1016/j.jcrc.2009.01.007. Epub 2009 Mar 27.

  PMID: 19327955 BACKGROUND

MeSH Terms

Conditions

Respiratory Paralysis; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Demosthenes Makris

CONTACT

+306943706079; appollon7@hotmail.com

APOSTOLOS-ALKIVIADIS MENIS

CONTACT

menis.ap.alk@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Critical Care Medicine

Study Record Dates

• First Submitted: December 22, 2018
• First Posted: January 14, 2019
• Study Start: June 29, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)