Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02278835
Status:
COMPLETED
Last Update Posted:
2014-10-30
First Post:
2014-10-02
Brief Title:
The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
To Analyze the Effectiveness of Respiratory Physiotherapy Techniques in the Post Operative Mitral Valve
Status:
COMPLETED
Status Verified Date:
2014-10
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:
None
Brief Summary:
This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques to prevent pulmonary collapse based in an score applied in the patients submitted of the mitral valve surgery after their ICU discharge
Patients were allocated in groups according their pulmonary function FVC forced vital capacity the respiratory muscle performance MIP maximal inspiratory pressure MEP maximal expiratory pressure the oxygenation level SpO2 the pulmonary auscultation respiratory frequency f the ability to expectorate and the functional independence
The group I was allocated those patients which presented decrease of up to 50 of forced vital capacity FVC of preoperative period SpO292 minimal pulmonary auscultation alterations frequency f between 15 and 25 ipm able to expectorate without assistance independence to sit respiratory In these patients were randomized for two interventions a Deep breathing exercises diaphragmatic exercises inspiratory sighs maximal inspiration exercises Each kind of exercises was repeated 10 times b volume-targeted incentive spirometer used Coach three sets of 10 repetitions
Patients allocated in the group II presented FVC 30 49 of preoperative period 88 SpO2 92 necessity of oxygen therapy abnormal pulmonary auscultation f 25 31ipm dependence to expectorate and to sit They were assisted by a Intermittent Positive Pressure Breathing IPPB with PEEP - through ventilator Bird Mark 7 with exhalation valve spring load set at 10 cmH2O b CPAP - 10 cmH2O associated with oxygen support to obtain SpO2 95 with electronic device Sullivan Each session consisted of 20 minutes twice daily one in the morning and another in the afternoon
All of the patients were conducted in effort to mobilize upper and lower limbs On the first day the patients walked at least 50 meters by increasing the distance to at least 150 meters on the fourth day Outcome measures were recorded at day 5 of the interventions
Patients were allocated in groups according their pulmonary function FVC forced vital capacity the respiratory muscle performance MIP maximal inspiratory pressure MEP maximal expiratory pressure the oxygenation level SpO2 the pulmonary auscultation respiratory frequency f the ability to expectorate and the functional independence
The group I was allocated those patients which presented decrease of up to 50 of forced vital capacity FVC of preoperative period SpO292 minimal pulmonary auscultation alterations frequency f between 15 and 25 ipm able to expectorate without assistance independence to sit respiratory In these patients were randomized for two interventions a Deep breathing exercises diaphragmatic exercises inspiratory sighs maximal inspiration exercises Each kind of exercises was repeated 10 times b volume-targeted incentive spirometer used Coach three sets of 10 repetitions
Patients allocated in the group II presented FVC 30 49 of preoperative period 88 SpO2 92 necessity of oxygen therapy abnormal pulmonary auscultation f 25 31ipm dependence to expectorate and to sit They were assisted by a Intermittent Positive Pressure Breathing IPPB with PEEP - through ventilator Bird Mark 7 with exhalation valve spring load set at 10 cmH2O b CPAP - 10 cmH2O associated with oxygen support to obtain SpO2 95 with electronic device Sullivan Each session consisted of 20 minutes twice daily one in the morning and another in the afternoon
All of the patients were conducted in effort to mobilize upper and lower limbs On the first day the patients walked at least 50 meters by increasing the distance to at least 150 meters on the fourth day Outcome measures were recorded at day 5 of the interventions
Detailed Description:
The study were conducted with individuals of both gender aged between 18 and 60 years candidates for mitral valve surgery up to a maximum 2nd valve replacement Patients unable to perform the functional tests were excluded and patients with signs of neurological disorders hemodynamic instability respiratory disorders and mechanically ventilated for more than 48 hours
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