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Effects of Preoperative Respiratory Physical Therapy on Postoperative Respiratory Function After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT01828632
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Julio Llorens, Fundación para la Investigación del Hospital Clínico de Valencia

Brief Summary:

Background. Morbidly obese patients show an increased risk of hypoxemia and a higher incidence of postoperative pulmonary complications during the postoperative period resulting in prolonged hospital length of stay when compared with normal weight subjects. Preoperative respiratory physiotherapy including inspiratory muscle training (IMT) has been shown to reduce the incidence of post operative respiratory complications in some different settings.

Objective. To determine wether a program of preoperative respiratory physical therapy could reduce the incidence and severity of postoperative hypoxemia in morbidly obese patients undergoing laparoscopic bariatric surgery.

Setting. Hospital Clínico Universitario, Valencia, Spain.

Design and Patients. A double-blind, randomized clinical trial. 50 patients (BMI≥40%) consecutively scheduled for laparoscopic bariatric surgery were included of whom 44 completed the study. Sample size was calculated using the repeated measures of the PaO2/FiO2 ratio along the postoperative period as the primary endpoint and considering an effect size of 0.25.

Interventions. Patients were randomly assigned to receive either preoperative respiratory physical therapy (n=23) or usual care (n=21) during a month just before the date of surgery. Both groups received the same postoperative physical therapy.

Measures. Data on oxygenation (primary outcome, PaO2/Fio2 ratio) were obtained at 1hour and at 12 hours after surgery. Data on spirometry and maximum static respiratory pressures (secondary outcomes) were obtained before and after the training period, and in the postoperative period.


Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Respiratory Physical Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Preoperative Respiratory Physical Therapy on Postoperative Respiratory Function in Morbidly Obese Patients Undergoing Bariatric Surgery. A Randomized, Controlled, Clinical Trial
Study Start Date : March 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Respiratory Physical Therapy
Patients assigned to interventional group (Respiratory Physical Therapy) were undergone a program of inspiratory muscular training (IMT) and incentive spirometer for a period of 30 days before the actual date of surgery. PiMAX, PeMAX and spirometry parameters were measured at the randomization day (baseline values)
Procedure: Respiratory Physical Therapy
Patients were randomly assigned to receive either a preoperative respiratory physiotherapy program (Intervention group, RPT) which included lung re-expansion (Incentive Spirometer, Voldyne5000, Teleflex medical USA) and respiratory muscle training (Threshold IMT, Respironics Inc. Pittsburgh, PA, USA) or usual care (Control group). Immediately after randomization the RPT group patients received detailed instructions about the training program and how correctly use the IMT and incentive spirometer devices. The patients trained daily, for 30 consecutive days. Each session consisted in 20 minutes of IMT and incentive spirometer. The patients adherence to the program was evaluated weekly by the physical therapist. Postoperative physical therapy was the same for both groups and consisted in lung re-expansion exercise with the aid of the incentive spirometer. Besides, patients were placed in sitting position rather than lying and early mobilization was stimulated.
Other Names:
  • Inspiratory muscle training
  • Incentive spirometer

No Intervention: Control
Usual care for the four weeks before surgery. PiMAX, PeMAX and spirometry parameters were measured at the randomization day (baseline values).



Primary Outcome Measures :
  1. Intergroup difference in Arterial Oxygen partial pressure / Inspired Oxygen Fraction ratio (PaO2/FiO2) [ Time Frame: Two Time Points: At one and at twelve hours after the patients's arrival to the post-anesthesia care unit ]

Secondary Outcome Measures :
  1. Intragroup and intergroup differences in Maximal Inspiratory Pressure (MIP) [ Time Frame: Two Time Points: At the end of the physiotherapy program and at twelve hours after the arrival to the PACU,compared with the baseline values. ]
  2. Intergroup difference in Arterial carbon dioxide (PaCO2) [ Time Frame: Two Time Points: At one and at twelve hours after the patients's arrival to the post-anesthesia care unit ]

Other Outcome Measures:
  1. Intragroup and intergroup spirometry values (FVC and FEV1) in the postoperative period [ Time Frame: Two Time Points: At one and at twelve hours after the patients's arrival to the PACU ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Adult morbidly obese patients (BMI>40%) consecutively scheduled for bariatric surgery

Exclusion Criteria:

  • Age > 65 years
  • Pregnancy
  • Severe psychiatric disorders
  • Disability to perform a valid spirometry and/or correctly use IMT and incentive spirometer devices
  • Bronchial asthma requiring regular therapy
  • Smoking less than two months before surgery
  • Chronic obstructive pulmonary disease
  • Restrictive lung disease or lung surgery
  • Cardiac disease associated with dyspnoea > NYHA II

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828632


Locations
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Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46021
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
Investigators
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Study Director: Julio Llorens, MD, PhD Hospital Clínico Universitario de Valencia. Spain.
Publications:

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Responsible Party: Julio Llorens, MD, PhD, Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT01828632    
Other Study ID Numbers: EC-08-2011
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: April 2013
Keywords provided by Julio Llorens, Fundación para la Investigación del Hospital Clínico de Valencia:
Obesity, Morbid; Hypoxemia; Postoperative complications; Bariatric surgery; Respiratory physical therapy; Preoperative care.
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight