Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

Surgery Clinical Trial

Official title:

Effect of Respiratory Muscle Training in Malnourished Patients Undergoing Upper Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200198
• Other study ID #: 0613/07
• Status: Completed
• Phase: N/A
• First received: July 23, 2014
• Last updated: July 24, 2014
• Start date: February 2011
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Malnutrition affects 50% of hospitalized patients around the world and causes changes in respiratory muscles predisposing the development of pulmonary complications probable, because of the ineffectiveness of cough. How the training of respiratory muscles can improve the effectiveness of cough, malnourished patients could benefit from this train however, the training of the muscles in malnourished patients has not been tested for safety or efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory muscle training to improve the potency of cough in malnourished patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hospitalized malnourished patients (BMI = 20 Kg/m2, loss of body weight = 10% unintentional, or serum albumin <3.5 g/dL)

• candidate to elective abdominal surgery

• ability to perform all evaluations and training

Exclusion Criteria:

• previous respiratory disease

• necessity of over than 48h of mechanical ventilation

• reoperation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malnutrition
• Surgery
• Undernutrition

Intervention

Other:
• Expiratory muscle training
Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold with Positive Expiratory Pressure with a load of 30% of maximal expiratory pressure assessed by digital peak respiratory pressure monitor
• Inspiratory muscle training
Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold for Inspiratory Muscle Training with a load of 30% of maximal inspiratory pressure assessed by digital peak respiratory pressure monitor
• Sham group
Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load

Locations

Country	Name	City	State
Brazil	Hospital of Clinics of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expiratory peak flow in spirometry	Assessed as expiratory peak flow in spirometry	on the 8th day of protocol (after 7 dyas of training)	Yes
Secondary	Maximum respiratory pressures	Assessed by digital peak respiratory pressure monitor as maximum inspiratory pressure and maximum expiratory pressure	on the 8th day of protocol (after 7 days of training)	Yes
Secondary	Postoperative pulmonary complication	The following pulmonary complications were considered: atelectasis with clinical consequences, hypoxemia with oxygen saturation <85%, and need for supplemental oxygen, pneumonia and acute respiratory failure.; The diagnosis of complication was performed by a physician who was blinded to the intervention group.	participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days	Yes