Sleep study, respiratory mechanics, chemosensitive response and quality of life in morbidly obese patients undergoing bariatric surgery: a prospective, randomized, controlled trial

Abstract

BackgroundObesity is a major public health problem in both developed and developing countries alike and leads to a series of changes in respiratory physiology. There is a strong correlation between obesity and cardiopulmonary sleep disorders. Weight loss among such patients leads to a reduction in these alterations in respiratory physiology, but clinical treatment is not effective for a long period of time. Thus, bariatric surgery is a viable option.Methods/DesignThe present study involves patients with morbid obesity (BMI of 40 kg/m2 or 35 kg/m2 to 39.9 kg/m2 with comorbidities), candidates for bariatric surgery, screened at the Santa Casa de Misericórdia Hospital in the city of Sao Paulo (Brazil). The inclusion criteria are grade III morbid obesity, an indication for bariatric surgery, agreement to participate in the study and a signed term of informed consent. The exclusion criteria are BMI above 55 kg/m2, clinically significant or unstable mental health concerns, an unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment. Bariatric surgery candidates who meet the inclusion criteria will be referred to Santa Casa de Misericórdia Hospital and will be reviewed again 30, 90 and 360 days following surgery. Data collection will involve patient records, personal data collection, objective assessment of HR, BP, neck circumference, chest and abdomen, collection and analysis of clinical preoperative findings, polysomnography, pulmonary function test and a questionnaire on sleepiness.DiscussionThis paper describes a randomised controlled trial of morbidly obese patients. Polysomnography, respiratory mechanics, chemosensitive response and quality of life will be assessed in patients undergoing or not undergoing bariatric surgery.Trial RegistrationThe protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC (RBR-9k9hhv).

Obstructive sleep apnea and pulmonary function in patients with severe obesity before and after bariatric surgery: a randomized clinical trial

“…A controlled, prospective, randomized clinical trial was carried out based on our previously published study protocol [14], following approval from the Human Research Ethics Committee of the Universidade Nove de Julho(Brazil) under protocol number 220506/2009. This study is registered with the World Health Organization (Universal Trial Number: U1111-1121-8873) and the Brazilian Registry of Clinical Trials (RBR-9k9hhv).…”

“…The anatomic references for waist and neck circumference measurements were standardized. Waist circumference was measured at the mid-point between the lower margin of the last rib and the iliac crest, whereas the neck circumference was measured horizontally at the level of the cricoid cartilage [14].…”

Assessment of the Body Composition and the Loss of Fat-Free Mass through Bioelectric Impedance Analysis in Patients Who Underwent Open Gastric Bypass

“…This study is related to protocol registered in the World Health Organization Universal Trial Number (UTN) U1111-1121-8873 and Registro Brasileiro de Ensaios Clínicos (RBR-9k9hhv) and has been approved by the Human Research Ethics Committees of the Nove de Julho University, São Paulo, Brazil (process number 220506/2009) [8]. All participants gave written informed consent.…”

“…A prospective study was carried out with patients subjected to bariatric surgery and conducted according to the ethical standards established in the 1961 Declaration of Helsinki (as revised in Hong Kong in 1989 and in Edinburgh, Scotland, in 2000). This study is related to protocol registered in the World Health Organization Universal Trial Number (UTN) U1111-1121-8873 and Registro Brasileiro de Ensaios Clínicos (RBR-9k9hhv) and has been approved by the Human Research Ethics Committees of the Nove de Julho University, São Paulo, Brazil (process number 220506/2009) [ 8 ]. All participants gave written informed consent.…”

Estudo do sono e função pulmonar em pacientes obesos mórbidos

“…Essa avaliação consistiu em coleta de dados pessoais do paciente, seguida de verificação dos seguintes itens: frequência cardíaca, frequência respiratória, pressão arterial sistêmica periférica, peso e altura, IMC, cirtometria do pescoço e abdômen, espirometria, manovacuometria, polissonografia basal noturna. Nessa oportunidade, procedeu-se também a aplicação do Questionário Clínico de Berlin e da Escala de Sonolência de Epworth, de acordo com protocolo de pesquisa previamente publicado (18).…”