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Completed

NCT Number: NCT02200198

Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

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.

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Key information

Conditions

Undernutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Clinics of Sao Paulo

São Paulo, 05403-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expiratory Muscle Training

Other

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

Other

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

Other

Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load

Primary outcomes

  1. Expiratory peak flow in spirometry

    Time frame: on the 8th day of protocol (after 7 dyas of training)

    Assessed as expiratory peak flow in spirometry

Secondary outcomes

  1. Maximum respiratory pressures

    Time frame: on the 8th day of protocol (after 7 days of training)

    Assessed by digital peak respiratory pressure monitor as maximum inspiratory pressure and maximum expiratory pressure

  2. Postoperative pulmonary complication

    Time frame: participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2014
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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