Weaning FailureNCT03802383
The Relationship Between Trans-diaphragmatic Pressure and Diaphragmatic Contraction
An observational study of Weaning Failure and Respiratory Paralysis, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, Respiratory Paralysis, Respiratory Failure
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 29 Jun 2018to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the Intensive Care Unit of the University Hospital of Larissa
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Obese patients with B.M.I. >35
- pregnant women
- patients <18 years old
Trial locations and contacts
1 site in 1 country.
APOSTOLOS-ALKIVIADIS MENIS contact
Greece1 site, 1 recruiting
- Recruiting
Critical Care Unit
Larissa, Thessaly
Dimosthenis Makris
About this study
Official title: A Study on the Relationship Between the Trans-diaphragmatic Pressure and the Contraction of the Diaphragm
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.
Read the 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.
- Conditions
- Weaning Failure, Respiratory Paralysis, Respiratory Failure
- Medical subject headings
- Respiratory Paralysis, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start29 Jun 2018
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DEMOSTHENES MAKRIS, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802383
- Sponsor's protocol ID
- 3531/29.06.2018
- Status last verified
- Mar 2024
- First submitted
- 22 Dec 2018
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 27334266Turnbull 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.
PubMed 17456490Beaulieu Y, Marik PE. Bedside ultrasonography in the ICU: part 1. Chest. 2005 Aug;128(2):881-95. doi: 10.1378/chest.128.2.881.
PubMed 16100182Beaulieu Y, Marik PE. Bedside ultrasonography in the ICU: part 2. Chest. 2005 Sep;128(3):1766-81. doi: 10.1378/chest.128.3.1766.
PubMed 16162786Matamis 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.
PubMed 23344830Goligher 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.
PubMed 25749574MacIntyre 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.
PubMed 11742959MILIC-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.
PubMed 14155283Baydur 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.
PubMed 7149443Bellemare 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.
PubMed 7174413Grinnan 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.
PubMed 16277736Vivier 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.
PubMed 22476448Yang 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.
PubMed 2023603Nemer 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.
PubMed 19327955
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Relationship Between the Trans-diaphragmatic Pressure and the Contraction of the Diaphragm
- ClinicalTrials.gov ID
- NCT03802383
- Acronym / sponsor ID
- 3531/29.06.2018
- Conditions
- Weaning Failure, Respiratory Paralysis, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the Intensive Care Unit of the University Hospital of Larissa
Key inclusion criteria (14 listed)
- Patients meeting the following standards.
- Respiratory Criteria
- Cardiovascular Criteria
- Adequate level of consciousness
- o Glasgow Coma Scale (GCS ≥ 13)
Key exclusion criteria (3 listed)
- Obese patients with B.M.I. >35
- pregnant women
- patients <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- BackgroundBrochard 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: PubMed 27334266Mauri 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.
- Background: PubMed 17456490Turnbull 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.
- Background: PubMed 16100182Beaulieu Y, Marik PE. Bedside ultrasonography in the ICU: part 1. Chest. 2005 Aug;128(2):881-95. doi: 10.1378/chest.128.2.881.
- Background: PubMed 16162786Beaulieu Y, Marik PE. Bedside ultrasonography in the ICU: part 2. Chest. 2005 Sep;128(3):1766-81. doi: 10.1378/chest.128.3.1766.
- Background: PubMed 23344830Matamis 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.
- Background: PubMed 25749574Goligher 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.
- Background: PubMed 11742959MacIntyre 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.
- Background: PubMed 14155283MILIC-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.
- Background: PubMed 7149443Baydur 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.
- Background: PubMed 7174413Bellemare 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.
- Background: PubMed 16277736Grinnan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
APOSTOLOS-ALKIVIADIS MENIS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure and Respiratory Paralysis, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Demosthenes Makris (+306943706079, appollon7@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03802383, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.