Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583371
Status:
UNKNOWN
Last Update Posted:
2020-10-12
First Post:
2020-09-29
Brief Title:
The Use of Pulmonary Hyperinflation With the Mechanical Ventilator in Cardiac Patients
Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Organization:
Instituto de Cardiologia do Rio Grande do Sul
Study Overview
Official Title:
Effect of the Use of Pulmonary Hyperinflation With Mechanical Ventilator Plus Aspiration Versus Isolated Tracheal Aspiration in Bronchial Hygiene in Patients With Heart Disease
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Mechanical ventilation MV is used to reduce work and reverse or prevent fatigue of the respiratory muscles decrease oxygen consumption and maintain gas exchange In addition to the benefits given to patients undergoing MV there is a high risk of accumulating bronchial secretions related to pathology and or therapeutic intervention Pulmonary hyperinflation is widespread in patients in intensive care centers ICUs as a bronchial hygiene therapy being used in 40 of 64 Australian ICUs as demonstrated by Dennis et al Through contact with physical therapists Mechanical hyperinflation associated with tracheal aspiration is able to increase the amount of secretion aspirated when compared to isolated aspiration in patients undergoing mechanical ventilation To assess whether the pulmonary hyperinflation maneuver with the mechanical ventilator compared to isolated tracheal aspiration increases the removal of secretions To evaluate whether the use of the pulmonary hyperinflation maneuver in the mechanical ventilator is hemodynamically stable through the collection in two moments of the variables of heart rate HR mean arterial pressure MAP peripheral saturation SpO2 respiratory rate RF that will be analyzed from the postoperative units multiparametric monitor
Evaluate the change in respiratory mechanics through collection in two moments after the mechanical hyperinflation technique through dynamic compliance Cdyn tidal air volume VAC peak pressure Ppico The population will consist of patients from the Post-Operative Unit UPO from the Institute of Cardiology of both sexes over 18 years old mechanically ventilated and the sample consisting of 50 individuals These will be submitted to the use of the pulmonary hyperinflation maneuver in the mechanical ventilator Randomized crossover clinical trial
Evaluate the change in respiratory mechanics through collection in two moments after the mechanical hyperinflation technique through dynamic compliance Cdyn tidal air volume VAC peak pressure Ppico The population will consist of patients from the Post-Operative Unit UPO from the Institute of Cardiology of both sexes over 18 years old mechanically ventilated and the sample consisting of 50 individuals These will be submitted to the use of the pulmonary hyperinflation maneuver in the mechanical ventilator Randomized crossover clinical trial
Detailed Description:
Mechanical ventilation MV is used to reduce work and reverse or prevent fatigue of the respiratory muscles decrease oxygen consumption and maintain gas exchange In addition to the benefits given to patients undergoing MV there is a high risk of accumulating bronchial secretions related to pathology and or therapeutic intervention Pulmonary hyperinflation is widespread in patients in intensive care centers ICUs as a bronchial hygiene therapy being used in 40 of 64 Australian ICUs as demonstrated by Dennis et al Through contact with physical therapists Mechanical hyperinflation associated with tracheal aspiration is able to increase the amount of secretion aspirated when compared to isolated aspiration in patients undergoing mechanical ventilation
To evaluate whether the use of the pulmonary hyperinflation maneuver in the mechanical ventilator is hemodynamically stable through the collection in two moments of the heart rate HR mean arterial pressure MAP peripheral saturation SpO2 respiratory rate RF variables that will be analyzed from the postoperative units multiparametric monitor
Evaluate the change in respiratory mechanics through collection in two moments after the mechanical hyperinflation technique through dynamic compliance Cdyn tidal air volume VAC peak pressure Ppico The population will consist of patients from the Post-Operative Unit UPO unit intensive care UCI and emergency room from the Institute of Cardiology of both sexes over 18 years old mechanically ventilated more than 48 hours and the sample consisting of 50 individuals These will be submitted to the use of the pulmonary hyperinflation maneuver in the mechanical ventilator
This is a randomized crossover clinical trial in which the individuals selected for the study will be randomized to receive isolated tracheal aspiration Control Group and pulmonary hyperinflation through the mechanical ventilator associated with tracheal aspiration Intervention Group Randomization will be performed through the randomizationcom website by a 1 1 crossed block allocating the patient to one of the groups and after 24 hours another technique will be performed In addition a control aspiration will be performed 2 hours before both techniques
For basal aspiration the patient will be placed in the supine position with the head elevated at 30º will be submitted to a single aspiration with a size 12 probe Mark Med with a vacuum adjusted to -40cmH2O of pressure with basic asepsis care being maintained for performing the technique35
In the control group patients will be ventilated for 1 minute with 100 inspired oxygen FiO2 followed by three aspirations for 15 seconds and with an interval of 30 seconds
In the participants of the intervention group the calculation of the ideal tidal volume for each patient will be performed after which they will be positioned in the supine position the head elevated to 30º in assisted pressure-controlled ventilation mode increasing 10 cmH2O in inspiratory pressure and in assisted ventilation mode controlled by volume we will increase 50 of the tidal volume for a period of 10 minutes observing the Ppeak that cannot exceed 40 cmH2O and the drive pressure that cannot exceed 15 cmH2O in both ventilation modes and then a new aspiration will be performed in the same way as the control group The hemodynamics data will be taken from the multiparametric monitor of the hospitalization units philips and the respiratory mechanics data will be collected from the mechanical ventilator screen Servo S Drager Newport before and after the techniques The volume of secretion will be stored in the collection flask Water Seal 120 ml and weighed using a high precision scale discounting the weight of the collection flask
The Informed Consent Form ICF will be signed by the responsible family member containing information and explanations about the present study and the researcher will be available to explain doubts and questions at the time and afterwards through the telephone present at the ICF All procedures will be performed under the supervision of the physiotherapist at the hospital It is understood that this research may offer a minimal risk to volunteers according to resolution 46612 of the National Health Council since they may have some discomfort and or their hemodynamic situation altered by the application of the aforementioned physical therapy technique As a counterpart in case the predicted risk occurs the subjects will receive all the necessary care from the researcher together with the units physiotherapist and medical team if necessary The benefits to the subjects refer to the possibility of improving their respiratory function and bronchial hygiene
To evaluate whether the use of the pulmonary hyperinflation maneuver in the mechanical ventilator is hemodynamically stable through the collection in two moments of the heart rate HR mean arterial pressure MAP peripheral saturation SpO2 respiratory rate RF variables that will be analyzed from the postoperative units multiparametric monitor
Evaluate the change in respiratory mechanics through collection in two moments after the mechanical hyperinflation technique through dynamic compliance Cdyn tidal air volume VAC peak pressure Ppico The population will consist of patients from the Post-Operative Unit UPO unit intensive care UCI and emergency room from the Institute of Cardiology of both sexes over 18 years old mechanically ventilated more than 48 hours and the sample consisting of 50 individuals These will be submitted to the use of the pulmonary hyperinflation maneuver in the mechanical ventilator
This is a randomized crossover clinical trial in which the individuals selected for the study will be randomized to receive isolated tracheal aspiration Control Group and pulmonary hyperinflation through the mechanical ventilator associated with tracheal aspiration Intervention Group Randomization will be performed through the randomizationcom website by a 1 1 crossed block allocating the patient to one of the groups and after 24 hours another technique will be performed In addition a control aspiration will be performed 2 hours before both techniques
For basal aspiration the patient will be placed in the supine position with the head elevated at 30º will be submitted to a single aspiration with a size 12 probe Mark Med with a vacuum adjusted to -40cmH2O of pressure with basic asepsis care being maintained for performing the technique35
In the control group patients will be ventilated for 1 minute with 100 inspired oxygen FiO2 followed by three aspirations for 15 seconds and with an interval of 30 seconds
In the participants of the intervention group the calculation of the ideal tidal volume for each patient will be performed after which they will be positioned in the supine position the head elevated to 30º in assisted pressure-controlled ventilation mode increasing 10 cmH2O in inspiratory pressure and in assisted ventilation mode controlled by volume we will increase 50 of the tidal volume for a period of 10 minutes observing the Ppeak that cannot exceed 40 cmH2O and the drive pressure that cannot exceed 15 cmH2O in both ventilation modes and then a new aspiration will be performed in the same way as the control group The hemodynamics data will be taken from the multiparametric monitor of the hospitalization units philips and the respiratory mechanics data will be collected from the mechanical ventilator screen Servo S Drager Newport before and after the techniques The volume of secretion will be stored in the collection flask Water Seal 120 ml and weighed using a high precision scale discounting the weight of the collection flask
The Informed Consent Form ICF will be signed by the responsible family member containing information and explanations about the present study and the researcher will be available to explain doubts and questions at the time and afterwards through the telephone present at the ICF All procedures will be performed under the supervision of the physiotherapist at the hospital It is understood that this research may offer a minimal risk to volunteers according to resolution 46612 of the National Health Council since they may have some discomfort and or their hemodynamic situation altered by the application of the aforementioned physical therapy technique As a counterpart in case the predicted risk occurs the subjects will receive all the necessary care from the researcher together with the units physiotherapist and medical team if necessary The benefits to the subjects refer to the possibility of improving their respiratory function and bronchial hygiene
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