Ignite Creation Date:
2024-05-06 @ 12:37 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03802383
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2018-12-22
Brief Title:
The Relationship Between Trans-diaphragmatic Pressure and Diaphragmatic Contraction
Sponsor:
University of Thessaly
Organization:
University of Thessaly
Study Overview
Official Title:
A Study on the Relationship Between the Trans-diaphragmatic Pressure and the Contraction of the Diaphragm
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Tdipi diaphragm thickness at end expiration Tdiee diaphragm thickening Tdipi - Tdiee diaphragm thickness fraction TFdiTdipi - TdieeTdiee diaphragm excursion Dec Maximal Inspiratory pressure MIP Pressure-Time product of the esophageal pressure PΤPesTension Time Diaphragm Index TTDi and the rapid shallow breathing index RSBI These measurements will be made in two phasesFirstly during the spontaneous breathing trial and secondly during spontaneous breathing through an airway of reduced diameterFurthermore during the MIP 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 SBT for sixty minutes During the SBT the desirable measurements will be made transdiaphragmatic pressure diaphragm thickening Tdipi Tdiee TFdi Die Maximal Inspiratory Pressure MIP Rapid Shallow Breathing Index RSBI If the SBT 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
1 The patient meets the SBT criteria
2 The patient is placed in a semi recumbent position
3 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
4 The balloons will be connected with a Hans Rudolph pneumotachograph for the measurement of the tidal volume the flow and the esophageal pressure
5 An occlusion test will be performed to make sure the esophageal balloon is correctly placed
6 Measurement of Pes Pgas and simultaneous sonographic measurements Diaphragm thickening Tdipi Tdiee Dex TFdi during the SBT with the patient being in t-tube
7 Performance of a MIP maneuver
8 Measurement of the same parameters during an SBT with an airway of reduced diameter resistive breathing
9 Performance of lung ultrasound for B-lines estimation at the end of SBT MIP and the resistive breathing
10 If the SBT is successful according to the RSBI the patient will be disconnected from the mechanical ventilation
11 Monitoring of the patient for the next 48 hours for the extubation respiratory distress syndrome or reintubation for another reason
12 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 its 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 05-1 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 015 are indicative of the diaphragmatic incapability to maintain spontaneous breathing for more than 45 minutes whence the naming of Ttdi critical
Ttdi PdiPdimaxxTixTtot
Rapid Shallow Breathing Index
Rapid Shallow Breathing Index RSBI 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
RSBI RRVt
It has been shown that an RSBI values below 105 breathsminL can predict a successful weaning
Maximal Inspiratory Pressure
Maximal Inspiratory Pressure MIP 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 MIP 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 Tdipi - Tdiee diaphragmatic thickness at end-expiration Tdiee and end-inspiration Tdipi diaphragmatic excursion Die 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
The patients will enter a Spontaneous Breathing Trial SBT for sixty minutes During the SBT the desirable measurements will be made transdiaphragmatic pressure diaphragm thickening Tdipi Tdiee TFdi Die Maximal Inspiratory Pressure MIP Rapid Shallow Breathing Index RSBI If the SBT 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
1 The patient meets the SBT criteria
2 The patient is placed in a semi recumbent position
3 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
4 The balloons will be connected with a Hans Rudolph pneumotachograph for the measurement of the tidal volume the flow and the esophageal pressure
5 An occlusion test will be performed to make sure the esophageal balloon is correctly placed
6 Measurement of Pes Pgas and simultaneous sonographic measurements Diaphragm thickening Tdipi Tdiee Dex TFdi during the SBT with the patient being in t-tube
7 Performance of a MIP maneuver
8 Measurement of the same parameters during an SBT with an airway of reduced diameter resistive breathing
9 Performance of lung ultrasound for B-lines estimation at the end of SBT MIP and the resistive breathing
10 If the SBT is successful according to the RSBI the patient will be disconnected from the mechanical ventilation
11 Monitoring of the patient for the next 48 hours for the extubation respiratory distress syndrome or reintubation for another reason
12 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 its 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 05-1 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 015 are indicative of the diaphragmatic incapability to maintain spontaneous breathing for more than 45 minutes whence the naming of Ttdi critical
Ttdi PdiPdimaxxTixTtot
Rapid Shallow Breathing Index
Rapid Shallow Breathing Index RSBI 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
RSBI RRVt
It has been shown that an RSBI values below 105 breathsminL can predict a successful weaning
Maximal Inspiratory Pressure
Maximal Inspiratory Pressure MIP 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 MIP 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 Tdipi - Tdiee diaphragmatic thickness at end-expiration Tdiee and end-inspiration Tdipi diaphragmatic excursion Die 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None