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

NCT01828632 | Completed

• 1 other identifier: EC-08-2011
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

Obesity, Morbid; Hypoxemia; Postoperative complications; Bariatric surgery; Respiratory physical therapy; Preoperative care.

Outcome Measures

Primary Outcomes (1)

• Intergroup difference in Arterial Oxygen partial pressure / Inspired Oxygen Fraction ratio (PaO2/FiO2)

  Two Time Points: At one and at twelve hours after the patients's arrival to the post-anesthesia care unit

Secondary Outcomes (2)

• Intragroup and intergroup differences in Maximal Inspiratory Pressure (MIP)

  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.

• Intergroup difference in Arterial carbon dioxide (PaCO2)

  Two Time Points: At one and at twelve hours after the patients's arrival to the post-anesthesia care unit

Other Outcomes (1)

• Intragroup and intergroup spirometry values (FVC and FEV1) in the postoperative period

  Two Time Points: At one and at twelve hours after the patients's arrival to the PACU

Study Arms (2)

Respiratory Physical Therapy

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual care for the four weeks before surgery. PiMAX, PeMAX and spirometry parameters were measured at the randomization day (baseline values).

Interventions

Respiratory Physical Therapy PROCEDURE

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.

Also known as: Inspiratory muscle training, Incentive spirometer

Respiratory Physical Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46021, Spain

Location

Related Publications (9)

• Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.

  PMID: 20071471 BACKGROUND

• Nguyen NT, Root J, Zainabadi K, Sabio A, Chalifoux S, Stevens CM, Mavandadi S, Longoria M, Wilson SE. Accelerated growth of bariatric surgery with the introduction of minimally invasive surgery. Arch Surg. 2005 Dec;140(12):1198-202; discussion 1203. doi: 10.1001/archsurg.140.12.1198.

  PMID: 16365242 BACKGROUND

• Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.

  PMID: 12456460 BACKGROUND

• Zavorsky GS, Hoffman SL. Pulmonary gas exchange in the morbidly obese. Obes Rev. 2008 Jul;9(4):326-39. doi: 10.1111/j.1467-789X.2008.00471.x. Epub 2008 Mar 4.

  PMID: 18331421 BACKGROUND

• Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.

  PMID: 15105237 BACKGROUND

• Whalen FX, Gajic O, Thompson GB, Kendrick ML, Que FL, Williams BA, Joyner MJ, Hubmayr RD, Warner DO, Sprung J. The effects of the alveolar recruitment maneuver and positive end-expiratory pressure on arterial oxygenation during laparoscopic bariatric surgery. Anesth Analg. 2006 Jan;102(1):298-305. doi: 10.1213/01.ane.0000183655.57275.7a.

  PMID: 16368847 BACKGROUND

• Hulzebos EH, Helders PJ, Favie NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL. Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial. JAMA. 2006 Oct 18;296(15):1851-7. doi: 10.1001/jama.296.15.1851.

  PMID: 17047215 BACKGROUND

• Fagevik Olsen M, Hahn I, Nordgren S, Lonroth H, Lundholm K. Randomized controlled trial of prophylactic chest physiotherapy in major abdominal surgery. Br J Surg. 1997 Nov;84(11):1535-8. doi: 10.1111/j.1365-2168.1997.02828.x.

  PMID: 9393272 BACKGROUND

• Dronkers J, Veldman A, Hoberg E, van der Waal C, van Meeteren N. Prevention of pulmonary complications after upper abdominal surgery by preoperative intensive inspiratory muscle training: a randomized controlled pilot study. Clin Rehabil. 2008 Feb;22(2):134-42. doi: 10.1177/0269215507081574. Epub 2007 Dec 5.

  PMID: 18057088 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Hypoxia; Postoperative Complications

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Pathologic Processes

Study Officials

• Julio Llorens, MD, PhD

  Hospital Clínico Universitario de Valencia. Spain.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 7, 2013
• First Posted: April 10, 2013
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 8, 2016

Record last verified: 2013-04

Locations

ES (1)