Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433076
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-19
Brief Title:
The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients A Prospective Observational Study
Sponsor:
Ramathibodi Hospital
Organization:
Ramathibodi Hospital
Study Overview
Official Title:
The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-05
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:
EFFORT-1
Brief Summary:
Over-assisted mechanical ventilation MV is linked to respiratory muscle disuse atrophy while under-assisted MV can lead to patient self-inflicted lung injury P-SILI or respiratory muscle injuries Both scenarios result in poor outcomes This hypothesis aims to demonstrate the association between the degree of respiratory effort which was measured by P01 predicted Pmus and predicted Δtranspulmonary pressure ΔPL with ventilator-free days VFD and 28-day mortality
Detailed Description:
Recently the lung and diaphragm protective strategy is an important consideration when providing mechanical ventilation to critically ill patients Although mechanical ventilation can be life-saving improper management can cause harm The harmful mechanical ventilator setting can result from over-assisted or under-assisted ventilation Over-assisted ventilation can be caused by too much ventilatory support or calming down patients with high dosages of sedative drugs or muscle relaxants which negatively affect the operation of the diaphragm leading to diaphragm muscle atrophy and weakness This can make it more difficult to weaning and lead to prolonged use of mechanical ventilation It appears that previous study found a correlation between percentage change in diaphragm thickness fraction as measured by ultrasound during the first week of mechanical ventilation and prolonged duration of mechanical ventilation extended length of stay in the ICU and complications Additionally in the study conclusions a diaphragm thickness fraction of 15-30 during the first three days of mechanical ventilation was associated with the shortest duration of mechanical ventilation and this may potentially help guide the management of respiratory support
On the other hand the effect of under-assist breathing or allowing excessive respiratory effort could be harmful Some reported in chronic obstructive pulmonary disease COPD exacerbation patients found that the increased negative intra-thoracic pressure potentially causes injury to the diaphragm sarcomeres which are the muscle fibers responsible for generating force during breathing and it was proportional to the degree of obstruction And compared light microscopy of the diaphragmatic muscles necropsy in patients who died of COPD with normal subjects They found muscular necrosis and accumulation of fibrosis and collagen deposits The cytoplasm was scattered disrupted and lipofuscin accumulation with hyper-eosinophilia was observed
In addition an excessive high respiratory effort can cause lung injury by patient-self known as patient self-inflicted lung injury P-SILI a theory first mentioned that the increased magnitude of negative intrathoracic pressure during inhalation may cause the fluid shift from the pulmonary capillaries to the alveoli causing pulmonary edema This is relevant to the observational studies that the occurrence of negative intrathoracic pressure during large inhalations in obstruction airway patients such as tracheal stenosis also results in pulmonary edema In latterly confirmed this hypothesis Subsequent studies have supported this phenomenon and overall could be explained through the increase of transpulmonary pressure pendelluft phenomenon and patient-ventilator asynchrony PVA
However no current studies determine the relationship between respiratory effort measurement during mechanical ventilation and clinical outcomes Therefore we conduct the study to determine the relationship between respiratory effort parameters and clinical outcomes
On the other hand the effect of under-assist breathing or allowing excessive respiratory effort could be harmful Some reported in chronic obstructive pulmonary disease COPD exacerbation patients found that the increased negative intra-thoracic pressure potentially causes injury to the diaphragm sarcomeres which are the muscle fibers responsible for generating force during breathing and it was proportional to the degree of obstruction And compared light microscopy of the diaphragmatic muscles necropsy in patients who died of COPD with normal subjects They found muscular necrosis and accumulation of fibrosis and collagen deposits The cytoplasm was scattered disrupted and lipofuscin accumulation with hyper-eosinophilia was observed
In addition an excessive high respiratory effort can cause lung injury by patient-self known as patient self-inflicted lung injury P-SILI a theory first mentioned that the increased magnitude of negative intrathoracic pressure during inhalation may cause the fluid shift from the pulmonary capillaries to the alveoli causing pulmonary edema This is relevant to the observational studies that the occurrence of negative intrathoracic pressure during large inhalations in obstruction airway patients such as tracheal stenosis also results in pulmonary edema In latterly confirmed this hypothesis Subsequent studies have supported this phenomenon and overall could be explained through the increase of transpulmonary pressure pendelluft phenomenon and patient-ventilator asynchrony PVA
However no current studies determine the relationship between respiratory effort measurement during mechanical ventilation and clinical outcomes Therefore we conduct the study to determine the relationship between respiratory effort parameters and clinical outcomes
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