Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494085
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Pressure Muscle Index and Threshold of Over-assistance During Pressure Support Ventilation
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
PressUre-Muscle-index to Identify Patients Desired Tidal Volume and the Threshold of Over-Assistance During Pressure Support Ventilation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
PUMA
Brief Summary:
Pressure support ventilation PSV is used to assist the breathing of the intubated patient with some pressure from the ventilator This support aims at avoiding excessive inspiratory effort while ensuring a certain degree of training of the patients inspiratory muscle Avoiding both minimal and excessive assistance is thus important for the optimal care of the intubated patient ensuring a lung and diaphragm protective ventilation with the goal to liberate the patient from the ventilator as soon as possible
Recently pressure-muscle-index PMI an index of inspiratory effort easy to be measured on the ventilator screen has been proposed to avoid excessive assistance in PSV This will be the first prospective study testing the effects of setting pressure support based on PMI to avoid excessive assistance on patients recovering from acute lung injury acute hypoxemic respiratory failure
Recently pressure-muscle-index PMI an index of inspiratory effort easy to be measured on the ventilator screen has been proposed to avoid excessive assistance in PSV This will be the first prospective study testing the effects of setting pressure support based on PMI to avoid excessive assistance on patients recovering from acute lung injury acute hypoxemic respiratory failure
Detailed Description:
First for each patient enrolled the investigators will perform 1 inspiratory and 3 expiratory occlusions separated at least by 30 seconds at clinical PSV to measure respiratory mechanics plateau pressure Pplat and respiratory system compliance Crs and elastance Ers and inspiratory effort and drive Pocc P01 PMI and Vt expressed in mlKg of predicted body weight
Second if PMI0 at baseline the investigators will set Pressure Support PS so that positive end-expiratory pressure PEEP PS ie Peak pressure Ppeak equals Pplat measured at baseline in order to make PMI0 If PMI0 at baseline the investigators will set PS so that PEEPPS equals Pplat measured at baseline then the investigators will perform an inspiratory occlusion and repeat the procedure until PMI0 The PS level at which PMI0 PSPMI0 and the corresponding breathing pattern tial volume Vt and respiratory rate RR will be used as reference for the study protocol After 5 minutes at PSPMI0 the investigators will perform 3 inspiratory and 3 expiratory occlusions separated at least by 30 seconds
Third each patient will undergo 3 steps of PS above 2 4 6 cmH2O and 3 below -2 -4 -6 cmH2O PSPMI0 in a randomized order Steps will be randomized using a simple sequence written within envelopes opened blindly by the investigators Each step will last 5 minutes or less if poorly tolerated see tolerance rules below At the end of each step the investigators will perform 1 inspiratory occlusion and 3 expiratory occlusions Each of the expiratory occlusion will be separated by 30 seconds in order to restore the patients breathing pattern The investigators will resume a 3-minutes clinical PS in between each step to minimize changes in PaCO2 If not yet comprised by the study steps each patient will undergo an adjunctive 5 minutes step at PS 0 zero cmH2O
The study protocol will last approximately 60 minutes The patient will be continuously monitored by a physician and a respiratory therapist
At the end of the study if different from clinically set PS the investigators will propose clinicians to adjust the PS to target PMI0 and a lung and diaphragm protective ventilation strategy following current literature Data about PS setting at the end of the study will be recorded in the case report form
Tolerance rules
Protocol will be stopped if heart rate 140 beatsmin increase in respiratory rate by 50 or more if not explained by ineffective effort hypotension systolic blood pressure 90 mmHg or hypertension systolic blood pressure 180 mmHg peripheral arterial oxygen saturation 90 for 5 minutes excessive use of accessory respiratory muscles diaphoresis agitation and the appearance of major abdominal or thoracic paradoxical movements If apnea would appear at high PS levels as described as overassistance the PS will be decreased to the next lower level PS will be set to not exceed a Ppeak of 30 cmH2O or a Vt of 12 mLkg of predicted bodyweight
Second if PMI0 at baseline the investigators will set Pressure Support PS so that positive end-expiratory pressure PEEP PS ie Peak pressure Ppeak equals Pplat measured at baseline in order to make PMI0 If PMI0 at baseline the investigators will set PS so that PEEPPS equals Pplat measured at baseline then the investigators will perform an inspiratory occlusion and repeat the procedure until PMI0 The PS level at which PMI0 PSPMI0 and the corresponding breathing pattern tial volume Vt and respiratory rate RR will be used as reference for the study protocol After 5 minutes at PSPMI0 the investigators will perform 3 inspiratory and 3 expiratory occlusions separated at least by 30 seconds
Third each patient will undergo 3 steps of PS above 2 4 6 cmH2O and 3 below -2 -4 -6 cmH2O PSPMI0 in a randomized order Steps will be randomized using a simple sequence written within envelopes opened blindly by the investigators Each step will last 5 minutes or less if poorly tolerated see tolerance rules below At the end of each step the investigators will perform 1 inspiratory occlusion and 3 expiratory occlusions Each of the expiratory occlusion will be separated by 30 seconds in order to restore the patients breathing pattern The investigators will resume a 3-minutes clinical PS in between each step to minimize changes in PaCO2 If not yet comprised by the study steps each patient will undergo an adjunctive 5 minutes step at PS 0 zero cmH2O
The study protocol will last approximately 60 minutes The patient will be continuously monitored by a physician and a respiratory therapist
At the end of the study if different from clinically set PS the investigators will propose clinicians to adjust the PS to target PMI0 and a lung and diaphragm protective ventilation strategy following current literature Data about PS setting at the end of the study will be recorded in the case report form
Tolerance rules
Protocol will be stopped if heart rate 140 beatsmin increase in respiratory rate by 50 or more if not explained by ineffective effort hypotension systolic blood pressure 90 mmHg or hypertension systolic blood pressure 180 mmHg peripheral arterial oxygen saturation 90 for 5 minutes excessive use of accessory respiratory muscles diaphoresis agitation and the appearance of major abdominal or thoracic paradoxical movements If apnea would appear at high PS levels as described as overassistance the PS will be decreased to the next lower level PS will be set to not exceed a Ppeak of 30 cmH2O or a Vt of 12 mLkg of predicted bodyweight
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