Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611527
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between Two Methods of Positive Pressure Therapy in the Prevention of Pulmonary Complications in the Immediate Postoperative Period of Cardiac Surgery a Prospective Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
PRO-LUNGHS
Brief Summary:
The most common cardiac surgeries are myocardial revascularization and valve replacement or plastic surgery In the postoperative period of cardiac surgeries the incidence of pulmonary complications ranges from 30 to 50 and is associated with increased length of hospital stay and morbidity and mortality To reduce or minimize the occurrence of these complications respiratory physiotherapy employs positive pressure reexpansion therapies such as continuous positive airway pressure CPAP and positive pressure support with positive end-expiratory pressure PSPEEP
The goal of this clinical trial is to compare the effects of two positive pressure therapies CPAP versus PSPEEP on the incidence of pulmonary complications in patients in the postoperative period of myocardial revascularization and valve replacement or plastic surgery with mild to moderate pulmonary dysfunction
The main question it aims to answer is Do patients in the immediate postoperative period of myocardial revascularization or valve replacementplastic surgery exhibiting mild to moderate pulmonary dysfunction experience a comparable reversal of pulmonary conditions when treated with PSPEEP versus CPAP
Participants will undergo the following assessments spirometry respiratory muscle strength testing handgrip strength testing and electrical impedance tomography
In the immediate postoperative period participants will be randomized into two treatment groups Control Group PSPEEP - application of 4 sets of 20 repetitions with PS to provide a tidal volume equal to 10mlkg of predicted body weight PEEP equal to 10 cmH2O and inspired oxygen fraction FiO2 to achieve peripheral oxygen saturation SpO2 between 92-94 Experimental Group CPAP - application of CPAP at 10 cmH2O with FiO2 to achieve SpO2 between 92-94 for 30 minutes
The goal of this clinical trial is to compare the effects of two positive pressure therapies CPAP versus PSPEEP on the incidence of pulmonary complications in patients in the postoperative period of myocardial revascularization and valve replacement or plastic surgery with mild to moderate pulmonary dysfunction
The main question it aims to answer is Do patients in the immediate postoperative period of myocardial revascularization or valve replacementplastic surgery exhibiting mild to moderate pulmonary dysfunction experience a comparable reversal of pulmonary conditions when treated with PSPEEP versus CPAP
Participants will undergo the following assessments spirometry respiratory muscle strength testing handgrip strength testing and electrical impedance tomography
In the immediate postoperative period participants will be randomized into two treatment groups Control Group PSPEEP - application of 4 sets of 20 repetitions with PS to provide a tidal volume equal to 10mlkg of predicted body weight PEEP equal to 10 cmH2O and inspired oxygen fraction FiO2 to achieve peripheral oxygen saturation SpO2 between 92-94 Experimental Group CPAP - application of CPAP at 10 cmH2O with FiO2 to achieve SpO2 between 92-94 for 30 minutes
Detailed Description:
None
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