Ventilators, Mechanical Clinical Trial
Official title:
Transpulmonary Pressure During Volume Controlled Mechanical Ventilation Versus Airway Pressure Release Ventilation for Hypoxic Respiratory Failure - a Randomized Feasibility Study
The study examines individuals admitted to the intensive care unit due to breathing difficulties resulting in not getting enough oxygen into their bodies. These patient will receive mechanical ventilation and this study aims to determine how the pressure inside the lungs changes when using two different modes of mechanical ventilation. The goal is to improve management and care of breathing difficulties by gaining insight into changes in lung pressure during mechanical ventilation, as well as comparing the effectiveness of the two ventilator modes.
As hypoxic respiratory failure is an acute condition, this trial will enrol temporarily incompetent patients and obtain consent from the patient's next of kin and an independent medical doctor (trial guardian) as soon as possible after enrolment. When included in the study, patients will be randomized 1:1 centrally in the RedCap system, using a computer-generated concealed assignment sequence, with permuted blocks of varying sizes, to start with either the intervention (APRV) followed by control (volume controlled mechanical ventilation) or control followed by intervention. Esophageal manometry will be used as a surrogate to measure the transpulmonary pressure. Arterial blood gasses, blood samples and lung ultrasound will be used to investigate oxygenation, ventilation and aeration. Treatment targets for both groups during the study are pH >7.20, saturation ≥ 88% and PaO2 ≥ 8.0 kPa, with FiO2 titrated as low as possible while complying to the oxygenation targets (PaO2 and saturation). Both arms start with an 'adjustment phase' where the ventilator is adjusted so the respiratory values are within the targets. The intervention adjustment phase is at least 30 minutes. The adjustments will follow standardized protocols. When the respiratory values are within range, the 'observation period begins' and no changes are made to the ventilator for 3 hours, unless it is necessary to achieve ventilatory treatment targets or deemed necessary by the treating physician. During the trial, the patient must be positioned in a supine position with the headboard elevated 0-30 degrees. After the first 'observation period', the patient is switched to the opposite ventilation mode and will go through an 'adjustment phase' and 'observation period' again. Once a patient regains competence, they will be provided with both written and oral information regarding the trial By comparing volume controlled mechanical ventilation and APRV and their transpulmonary pressures, valuable insight can be gained regarding optimal ventilation strategy for patients with hypoxic respiratory failure. Understanding how various ventilation modes influence transpulmonary pressure and their potential effects on respiratory mechanics can potentially inform designs of trials with individualized respiratory care. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05161962 -
Oral Care to Prevent Ventilator-associated Pneumonia
|
N/A | |
Terminated |
NCT02903407 -
Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU
|
Phase 4 | |
Enrolling by invitation |
NCT04520893 -
Ventilation Strategy for the Elderly Patients in Prone Position
|
N/A | |
Completed |
NCT03180203 -
Postoperative INTELLiVENT-ASV Ventilation
|
N/A | |
Completed |
NCT03497559 -
Music Use for Sedation In Critically Ill Children
|
N/A | |
Recruiting |
NCT03439683 -
KAP Asynchrony Survey
|
||
Recruiting |
NCT05270018 -
Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP
|
N/A | |
Recruiting |
NCT04841746 -
Efficacy of FES Cycling After a Severe Form of COVID-19
|
N/A | |
Not yet recruiting |
NCT06468436 -
Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients
|
N/A | |
Recruiting |
NCT04731532 -
Comparison of Thoracic Vibration With Classical Respiratory Physiotherapy in Patients With Mechanical Ventilation
|
N/A | |
Not yet recruiting |
NCT06147674 -
Evaluation of VQm PHM on Pulmonary Health Parameters for ICU
|
||
Enrolling by invitation |
NCT05759013 -
Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation
|
N/A | |
Completed |
NCT02989246 -
Effort of Breathing Guided Ventilator Protocol
|
N/A | |
Completed |
NCT00211016 -
Doripenem in the Treatment of Ventilator-Associated Pneumonia
|
Phase 3 | |
Recruiting |
NCT03376711 -
Development & Pilot RCT of an Online Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals
|
N/A |