Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293976
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-02-20
Brief Title:
Susceptibility for Entrainment Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Susceptibility for Entrainment Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study
Status:
RECRUITING
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:
SEVERE
Brief Summary:
Background Reverse triggering RT is a frequent phenomenon observed in sedated patients under a mechanical ventilation mode called assist-control ventilation RT is when the ventilator would trigger the patients respiratory effort instead of the correct order of the patients respiratory effort triggering the ventilator Reverse triggering can have negative consequences loss of protective lung ventilation and causing double breaths - with the ventilator giving two consecutive breaths and not allowing the patient to exhale but also offer some protective effects avoid diaphragm disuse atrophy The balance of its negative vs positive effects depends on its frequency and magnitude of its associated respiratory effort Respiratory entrainment is the most often referred mechanism involving a change in patients rate of breathing effort from that of patients intrinsic rate to the rate of mechanical insufflation The specific ventilatory settings associated with or responsible for RT remains unknown
Aims To assess in mechanically ventilated critically ill patients the influence of the set respiratory rate RR and tidal volume Vt on the presencedevelopment of RT and to describe the pattern of respiratory muscle activity during Reverse Triggering RT
Methods 30 adult patients 15 in each group sedated and under assist-controlled ventilation will be included Ventilator settings will be modified to modulate the frequency and magnitude of reverse triggering Initially with the ventilator on a mode called volume control which means the ventilator controls the amount of air tidal volume and the number of breaths the patients gets every minute respiratory rate RR The tidal volume will be set at the current standard clinical practice setting 6 mlkg of predicted body weight The presence of an intrinsic respiratory rate will be assessed with an end-expiratory occlusion maneuver Next the number of breaths the ventilator gives per minute RR will be changed from 6 breaths less to 6 breaths more in steps of 2 breaths every minute The protocol will be repeated again changing the amount of air the patients gets tidal volume from 4 5 7 and 8 mlkg Continuous recordings of airway pressure flow esophageal pressure electrical activity of the diaphragm main accessory muscles and frontal electroencephalography will be obtained during the protocol and baseline clinical and physiological characteristics and outcomes will be recorded A validated software will be used to detect RT and measure the intensity and timing of each muscle electrical activity and the magnitude of the inspiratory effort during RT
Aims To assess in mechanically ventilated critically ill patients the influence of the set respiratory rate RR and tidal volume Vt on the presencedevelopment of RT and to describe the pattern of respiratory muscle activity during Reverse Triggering RT
Methods 30 adult patients 15 in each group sedated and under assist-controlled ventilation will be included Ventilator settings will be modified to modulate the frequency and magnitude of reverse triggering Initially with the ventilator on a mode called volume control which means the ventilator controls the amount of air tidal volume and the number of breaths the patients gets every minute respiratory rate RR The tidal volume will be set at the current standard clinical practice setting 6 mlkg of predicted body weight The presence of an intrinsic respiratory rate will be assessed with an end-expiratory occlusion maneuver Next the number of breaths the ventilator gives per minute RR will be changed from 6 breaths less to 6 breaths more in steps of 2 breaths every minute The protocol will be repeated again changing the amount of air the patients gets tidal volume from 4 5 7 and 8 mlkg Continuous recordings of airway pressure flow esophageal pressure electrical activity of the diaphragm main accessory muscles and frontal electroencephalography will be obtained during the protocol and baseline clinical and physiological characteristics and outcomes will be recorded A validated software will be used to detect RT and measure the intensity and timing of each muscle electrical activity and the magnitude of the inspiratory effort during RT
Detailed Description:
Participants Critically ill patients n 30 aimed recruitment of equal numbers of men and women aged 18 years or older admitted to the St Michaels Hospital Unity Health Toronto Ontario Canada
Inclusion criteria
patients intubated for more than 12 hours
exposed to sedation for at least 6 hours
with a sedation-agitation score 4
and corresponding to one of the following categories based on bedside inspection of ventilator waveforms
1 patients on assist-control ventilation having reverse triggering at clinical settings n 15
2 patients on assist-control ventilation without reverse triggering at the clinical settings n 15
Exclusion criteria
primary severe neurological disorders
previous lung transplant
contraindications for esophageal catheter insertion
current use of continuous neuromuscular blocking agents at the time of the study procedure
severe metabolic acidosis pH 725 at the time of study procedure Study design Briefly first the ventilator Vt is set at 6 mlkg of predicted body weight PBW ie clinical practice recommendation and either a up to 30sec-long or two inspiratory efforts end-expiratory occlusion maneuver will be performed on the ventilator or the patient will be switched to pressure support for 30 - 60 sec based on discussion with the clinical team to assess the presence or absence of patients intrinsic RR
Secondly the influence of the ventilator RR on both the occurrence of reverse triggering and the level of effort associated with the reverse triggered breath will be assessed In random order the ventilator RR will be modified from 6 bpm below up to 6 bpm above the clinical RR in steps of 2 bpm every 1 minute Figure 1 A 1-minute stage at the patients clinical settings of ventilation in-between each step will be performed to minimize changes in PaCO2
Thirdly the influence of the Vt set on the ventilator on both the occurrence of reverse triggering and the level of effort associated with the reverse triggered breath will be assessed The ventilator Vt will be set to 5 mlkg PBW 7 and 8 mlkg PBW in random order and for each volume repeat the sequence described in the paragraph above A 1-minute clinical settings ventilation will be performed in-between each step to minimize changes in PaCO2
Next the patient will be returned to their initial clinical settings Another end-expiratory occlusion of up to 30 seconds or two inspiratory efforts or switch the patient to pressure support for 30 - 60 sec based on discussion with the clinical team will be performed to search for an intrinsic RR ie intrinsic respiratory drive If an intrinsic respiratory rate 8 breaths per minute is present and PF ratio is 150 it will propose to the clinician to place the patient in pressure support at a level preferred by clinicians for 5 minutes If the patient tolerates well 5 minutes in pressure support it be will propose to the clinician to maintain the patient in pressure support ventilation
The steps described above will be aborted at any point if SpO2 drops below 85 for at least two minutes mean arterial pressure drops below 60 mmHg or plateau pressure 35 cmH2O
Additionally the ventilator waveforms and electroencephalography EEG will be recorded continuously for the next 24 hours to investigate whether the presence of intrinsic RR was associated with changes in the ventilation mode by the clinician and brain activity
Inclusion criteria
patients intubated for more than 12 hours
exposed to sedation for at least 6 hours
with a sedation-agitation score 4
and corresponding to one of the following categories based on bedside inspection of ventilator waveforms
1 patients on assist-control ventilation having reverse triggering at clinical settings n 15
2 patients on assist-control ventilation without reverse triggering at the clinical settings n 15
Exclusion criteria
primary severe neurological disorders
previous lung transplant
contraindications for esophageal catheter insertion
current use of continuous neuromuscular blocking agents at the time of the study procedure
severe metabolic acidosis pH 725 at the time of study procedure Study design Briefly first the ventilator Vt is set at 6 mlkg of predicted body weight PBW ie clinical practice recommendation and either a up to 30sec-long or two inspiratory efforts end-expiratory occlusion maneuver will be performed on the ventilator or the patient will be switched to pressure support for 30 - 60 sec based on discussion with the clinical team to assess the presence or absence of patients intrinsic RR
Secondly the influence of the ventilator RR on both the occurrence of reverse triggering and the level of effort associated with the reverse triggered breath will be assessed In random order the ventilator RR will be modified from 6 bpm below up to 6 bpm above the clinical RR in steps of 2 bpm every 1 minute Figure 1 A 1-minute stage at the patients clinical settings of ventilation in-between each step will be performed to minimize changes in PaCO2
Thirdly the influence of the Vt set on the ventilator on both the occurrence of reverse triggering and the level of effort associated with the reverse triggered breath will be assessed The ventilator Vt will be set to 5 mlkg PBW 7 and 8 mlkg PBW in random order and for each volume repeat the sequence described in the paragraph above A 1-minute clinical settings ventilation will be performed in-between each step to minimize changes in PaCO2
Next the patient will be returned to their initial clinical settings Another end-expiratory occlusion of up to 30 seconds or two inspiratory efforts or switch the patient to pressure support for 30 - 60 sec based on discussion with the clinical team will be performed to search for an intrinsic RR ie intrinsic respiratory drive If an intrinsic respiratory rate 8 breaths per minute is present and PF ratio is 150 it will propose to the clinician to place the patient in pressure support at a level preferred by clinicians for 5 minutes If the patient tolerates well 5 minutes in pressure support it be will propose to the clinician to maintain the patient in pressure support ventilation
The steps described above will be aborted at any point if SpO2 drops below 85 for at least two minutes mean arterial pressure drops below 60 mmHg or plateau pressure 35 cmH2O
Additionally the ventilator waveforms and electroencephalography EEG will be recorded continuously for the next 24 hours to investigate whether the presence of intrinsic RR was associated with changes in the ventilation mode by the clinician and brain activity
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