Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627686
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Predictive Value of Airway Occlusion Pressure Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients With Traumatic Brain Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Predictive Value of Airway Occlusion Pressure Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients With Traumatic Brain Injury Observational Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study will be to measure the predictive power of the respiratory muscle determinants including The maximal inspiratory pressure and central drive determinant including Airway occlusion pressure and ratio between them in weaning outcome of traumatic brain injury patients undergoing invasive mechanical ventilation
Detailed Description:
Before spontaneous breathing trials with a T-piece for 30 min with an FIO2 of 040 measurements will be performed for a 20-second period Three parameters will be analyzed PImax P01 and P01PImax PImax and P01 will be obtained using a unidirectional valve method and a manovacuometer Instrumentation Industries Bethel Park PA attached to the airway
The device will have a scale of 30 cm H2O with a 1 cm H2O interval and will be designed to perform measurements at each 01 second Prior to testing all subjects will be on pressure support ventilation mode 12-20 cm H2O and will not be on sedatives The head of the subjects bed will be elevated to 45 degrees and the cuff of the artificial airway will be hyperinflated to prevent air leakage during measurement
The subject will have the airway clear of secretions by suctioning with standard tracheal suction procedures after pre-oxygenation for 2 minutes with FIO2 of 10
After a brief rest period pre-oxygenation will be repeated The subject will then be disconnected from mechanical ventilation and allowed to breathe spontaneously for 10 seconds before connecting the artificial airway to the manovacuometer when the subject will at functional residual capacity The subject will continuously be monitored by pulse oximetry and electrocardiogram and will have continual respiratory physiotherapist attention
For the present study respiratory drive P01 will be calculated as an average of the measured inspiratory pressure 01 s after the initiation of the inspiration for the first 3 cycles and P01PImax as the ratio of absolute values of P01 and PImax The subjects will not coached for the maneuver Thresholds for the 3 parameters will be calculated from their respective receiver operating characteristic ROC curves Values more negative than -25 cm H2Owere used to predict successful weaning
Weaning will be considered successful if spontaneous breathing will sustained for 48 hours after withdrawal from mechanical ventilation
The trial will stopped if at least one of the following intolerance criteria present SaO2 less than 90 or PaO2 less than 60 mm Hg with FIO2 greater than 04 PaCO2 greater than mm Hg or increased by 8 mm Hg or more arterial pH less than 733 or decreased by 007 or more respiratory rate greater than 35 breaths min or increased by 50 for 5 min or longer heart rate greater than 140 beatsmin or a sustained increase or decrease in 20 mean blood pressure greater than 130mmHg or less than 70mmHg or presence of agitation diaphoresis disorientation or depressed mental status
The subjects who will demonstrate one of these signs during the spontaneous breathing trial or within 48 hours after the discontinuation from mechanical ventilation will be considered not weaned and will returne to ventilator support
Before being submitted to spontaneous breathing trials SBTs of 2 hours patients will have the tracheal P 01 and the PImax measured P 01PImax ratio will then be calculated
Traditional thresholds will be adopted for the 3 parameters Tracheal P 01 will be measured in pressure support ventilation with pressure support in 7 cm H2O and positive end expiratory pressure in 5 cm H2O At least 3 measurements separated by an interval of not less than 15 seconds will be obtained and the mean value will be used for analysis Tracheal P 01 values less than 42 cm H2O will be used to predict successful weaning
P 01PImax ratio will be obtained through the division of tracheal P 01 by PImax and because both of them in reality are negative pressures the result will expressed in positive values Values smaller than 014 will be used to predict successful weaning
4- Patients who will pass SBT without deterioration will extubated and receive oxygen through Venturi mask 40 However SBT failure will be considered if the patient develop a decreased level of consciousness diaphoresis RR35 breathsmin hemodynamic instability heart rate140 systolic blood pressure180 or 90 mmHg or signs of increased work of breathing
The device will have a scale of 30 cm H2O with a 1 cm H2O interval and will be designed to perform measurements at each 01 second Prior to testing all subjects will be on pressure support ventilation mode 12-20 cm H2O and will not be on sedatives The head of the subjects bed will be elevated to 45 degrees and the cuff of the artificial airway will be hyperinflated to prevent air leakage during measurement
The subject will have the airway clear of secretions by suctioning with standard tracheal suction procedures after pre-oxygenation for 2 minutes with FIO2 of 10
After a brief rest period pre-oxygenation will be repeated The subject will then be disconnected from mechanical ventilation and allowed to breathe spontaneously for 10 seconds before connecting the artificial airway to the manovacuometer when the subject will at functional residual capacity The subject will continuously be monitored by pulse oximetry and electrocardiogram and will have continual respiratory physiotherapist attention
For the present study respiratory drive P01 will be calculated as an average of the measured inspiratory pressure 01 s after the initiation of the inspiration for the first 3 cycles and P01PImax as the ratio of absolute values of P01 and PImax The subjects will not coached for the maneuver Thresholds for the 3 parameters will be calculated from their respective receiver operating characteristic ROC curves Values more negative than -25 cm H2Owere used to predict successful weaning
Weaning will be considered successful if spontaneous breathing will sustained for 48 hours after withdrawal from mechanical ventilation
The trial will stopped if at least one of the following intolerance criteria present SaO2 less than 90 or PaO2 less than 60 mm Hg with FIO2 greater than 04 PaCO2 greater than mm Hg or increased by 8 mm Hg or more arterial pH less than 733 or decreased by 007 or more respiratory rate greater than 35 breaths min or increased by 50 for 5 min or longer heart rate greater than 140 beatsmin or a sustained increase or decrease in 20 mean blood pressure greater than 130mmHg or less than 70mmHg or presence of agitation diaphoresis disorientation or depressed mental status
The subjects who will demonstrate one of these signs during the spontaneous breathing trial or within 48 hours after the discontinuation from mechanical ventilation will be considered not weaned and will returne to ventilator support
Before being submitted to spontaneous breathing trials SBTs of 2 hours patients will have the tracheal P 01 and the PImax measured P 01PImax ratio will then be calculated
Traditional thresholds will be adopted for the 3 parameters Tracheal P 01 will be measured in pressure support ventilation with pressure support in 7 cm H2O and positive end expiratory pressure in 5 cm H2O At least 3 measurements separated by an interval of not less than 15 seconds will be obtained and the mean value will be used for analysis Tracheal P 01 values less than 42 cm H2O will be used to predict successful weaning
P 01PImax ratio will be obtained through the division of tracheal P 01 by PImax and because both of them in reality are negative pressures the result will expressed in positive values Values smaller than 014 will be used to predict successful weaning
4- Patients who will pass SBT without deterioration will extubated and receive oxygen through Venturi mask 40 However SBT failure will be considered if the patient develop a decreased level of consciousness diaphoresis RR35 breathsmin hemodynamic instability heart rate140 systolic blood pressure180 or 90 mmHg or signs of increased work of breathing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None