- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03802383
The Relationship Between Trans-diaphragmatic Pressure and Diaphragmatic Contraction
A Study on the Relationship Between the Trans-diaphragmatic Pressure and the Contraction of the Diaphragm
Study Overview
Status
Detailed Description
Protocol
The patients will enter a Spontaneous Breathing Trial (S.B.T.) for sixty minutes. During the S.B.T. the desirable measurements will be made: transdiaphragmatic pressure, diaphragm thickening, Tdi,pi , Tdi,ee , TFdi, Di,e, Maximal Inspiratory Pressure (M.I.P.) , Rapid Shallow Breathing Index (R.S.B.I.). If the S.B.T. is successful then the patient will be removed from the mechanical ventilator. For the next 48 hours the patient will be monitored for distress signs and thus be reintubated or if the weaning of the patient was successful extubation.
Flow chart of the study
- The patient meets the S.B.T. criteria.
- The patient is placed in a semi recumbent position.
- A nasogastric tube attached with two balloons, which are connected with a pressure transducer, one placed in the stomach and the other one in the lower third of the esophagus.
- The balloons will be connected with a Hans Rudolph pneumotachograph for the measurement of the tidal volume, the flow and the esophageal pressure.
- An occlusion test will be performed to make sure the esophageal balloon is correctly placed.
- Measurement of Pes, Pgas and simultaneous sonographic measurements (Diaphragm thickening, Tdipi, Tdiee, Dex, TFdi) during the S.B.T. with the patient being in t-tube.
- Performance of a MIP maneuver.
- Measurement of the same parameters during an S.B.T. with an airway of reduced diameter (resistive breathing).
- Performance of lung ultrasound for B-lines estimation at the end of SBT, MIP and the resistive breathing)
- If the S.B.T. is successful according to the R.S.B.I. the patient will be disconnected from the mechanical ventilation.
- Monitoring of the patient for the next 48 hours, for the extubation respiratory distress syndrome or reintubation for another reason.
- Further monitoring for 30 days in order to measure the time spent in mechanical ventilation
Definitions
Transdiaphragmatic pressure
Pdi will be measured with the use of a nasogastric catheter which has 2 balloons attached at 25 cm and 10 cm from it's distal end. The balloons, of 7 cm length, will be connected with a pressure transducer and with the use of a linear pneumotachometer Hans Rudolph RSS 100HR the graphic representation of the pressures will be displayed in a computer monitor. The balloons will contain 0,5-1 ml of air and will be placed in the stomach and the lower third of the esophagus. To ensure the correct positioning of the balloons an occlusion test (Baydur test) will be performed ,where the similar fluctuations between the esophageal and the airway pressure will be affirmative. As long as the stomach balloon is concerned the positive pressures during the inspiration will be affirmative of the correct positioning.
Tension Time Diaphragm Index
Ttdi is used as an index of diaphragmatic exhaustion. Measurements above 0,15 are indicative of the diaphragmatic incapability to maintain spontaneous breathing for more than 45 minutes, whence the naming of Ttdi critical
Ttdi = (Pdi/Pdi,max)x(TixTtot)
Rapid Shallow Breathing Index
Rapid Shallow Breathing Index (R.S.B.I.) is a method used for predicting the weaning outcome. It is measured during spontaneous breathing and equates to the ratio of respiratory rate per minute (RR) to the tidal volume (Vt) expressed in liters.
R.S.B.I. = RR/Vt
It has been shown that an R.S.B.I. values below 105 breaths/min/L can predict a successful weaning.
Maximal Inspiratory Pressure
Maximal Inspiratory Pressure (M.I.P.) is used as a predictive factor of the weaning outcome. It is measured with a manometer placed in a fully occluded airway, while the patient tries to breathe through it for 20 seconds. The highest pressure value is named M.I.P. It has been shown that values below -25 cmH2O are indicative of a positive weaning outcome.
Pressure-Time Product of the Esophageal pressure
PTPes was calculated as the area enclosed within the Pes trace, the superimposed recoil of the chest wall and onset and end of inspiratory flow. The chest wall recoil pressure was calculated as 4% of predicted vital capacity.
Diaphragm Ultrasound
The diaphragmatic function is assessed during spontaneous breathing and during breathing with an airway of reduced diameter. The diaphragmatic movement is assessed with ultrasound (Phillips iE33) using a Linear 3-11 MHz head. The ultrasound probe is placed in the mid axillary line perpendicular to the zone of apposition between the 8th-10th intercostal spaces. In this position, the diaphragm is shown as a non-echogenic layer between two echogenic layers which represent the diaphragmatic pleura and the abdominal peritoneum. With this technique the diaphragmatic thickening (Tdi,pi - Tdi,ee), diaphragmatic thickness at end-expiration (Tdi,ee) and end-inspiration (Tdi,pi), diaphragmatic excursion Di,e and diaphragmatic thickening fraction TFdi are measured. All the measurements are made using M-Mode Sonography.
Lung Ultrasound
Lung ultrasound (LUS) was performed in the anterior chest to estimate the number of B-Lines at the end of each phase. A restrictive two-region LUS test, conducted in the anterior chest region, was considered to assess EVLW during these maneuvers. Lung ultrasound was conducted at the end of SBT, MIP and RBT to evaluate for the generation of B-lines during each of these phases. Afterwards patients were categorized, according to the number of B-lines present, in four categories depending on the total number of B-lines 0: 0 B-lines, 1: 1-2 B-lines, 2: 3-7 B-lines, 3: >7 B-lines.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Demosthenes Makris
- Phone Number: +306943706079
- Email: appollon7@hotmail.com
Study Contact Backup
- Name: APOSTOLOS-ALKIVIADIS MENIS
- Email: menis.ap.alk@gmail.com
Study Locations
-
-
Thessaly
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Larissa, Thessaly, Greece
- Recruiting
- Critical Care Unit
-
Contact:
- Dimosthenis Makris
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3531/29.06.2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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