跳至主要内容
临床试验/NCT04805476
NCT04805476已完成不适用

Prophylactic Use of Noninvasive Ventilation in the Postoperative Period of Bariatric Surgery

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Forced Vital Capacity (FVC)

研究概览

简要总结

Comorbidities associated with severe obesity determine an important public health problem. Few methods are considered potentially effective for the treatment of severe obesity and the clinical relevance of bariatric surgery is growing, as well as the number of procedures performed. The insertion of the physiotherapist in the multiprofessional team responsible for performing the surgical procedure is essential from the preoperative screening and evaluation to the prevention and treatment of postoperative complications. Therefore, the physiopathological aspects involved with severe obesity, the technical aspects and risks of the surgical procedure, as well as the physiotherapeutic techniques that have scientific proof must be known by the physiotherapist responsible for the surgical follow-up of the patient. In this context, the use of non-invasive ventilation (NIV) in the postoperative period of bariatric surgery has ample therapeutic potential. The present research project aims to evaluate the immediate prophylactic use of NIV on the respiratory and functional recovery of the patients.

详细描述

The study will be performed at the surgical center of the Hospital de Clínicas of Porto Alegre. After approval by the Research Ethics Committee, patients must sign the Term of Consent for inclusion in the study. A blinded investigator will record clinical, anthropometric, pulmonary function tests, and functional measures. Patients submitted to open bariatric surgery will be divided into two groups for the use of NIV: immediate post-extubation (IG) and non-intervention (standard group [GP]). Patients will be randomly assigned to the groups. All subjects will undergo general anesthesia and postoperative analgesia, using a standardized surgical team approach. Patients who present the contraindication criteria for the use of NIV will be excluded from the study.

After the surgical procedure and extubation, GP subjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to the team routine and patient need. The subjects in the immediate intervention group (GI) will be extubated and placed in NIV the moment they enter the recovery room through a portable ventilator (Esprit ® or BiPAP Vision ®, Respironics) in face mask. The parameters will be adjusted as follows: FiO2 = 50%, positive expiratory pressure (EPAP, starting at 4-6 cmH2O and adjusting 1-2 cmH2O to avoid snoring, apnea, paradoxical breathing and desaturations) and adjusted inspiratory positive pressure (IPAP) to maintain a tidal volume of 400 to 500 ml, maintaining IPAP <15cmH2O17. Individuals will receive this ventilatory support for 1 hour. After this period the patients will be submitted to the same care of GP patients. Measurement of respiratory muscle strength and lung function will be recorded in Time 1 (in the preoperative period), Time 2 (at the time of entry of the recovery room) and Time 3 (1 hour after extubation, with withdrawal of the support ventilatory). Vital signs (heart rate, peripheral O2 Saturation and Blood Pressure) will also be recorded through the multi-parameter monitor (IntelliVue MP40).

The functional evaluation will be performed in the period of the initial data collection through the Functional Status Score for the ICU (FSS-ICU) and Functional Independence Measure (MIF). Patients will be monitored during the hospitalization period until hospital discharge and records of postoperative complications (radiological changes, infections and surgical anastomosis fistulas) will be recorded by blinded evaluator. The final evaluation will be done through the MIF, through telephone contact 1 month after the surgery.

During the study participation patients may present with discomfort, nausea, vomiting and / or pain related to the use of non-invasive ventilation and procedures performed to evaluate muscle strength, lung function and functionality. In a study with methodology and similar population, such risks / complications were not reported16, however, if they occur, the procedures will be immediately interrupted and patients will be assisted by the study researchers in order to preserve the patients and the reliability of the results.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients undergoing bariatric surgery

排除标准

  • •Absolute or relative contraindications to the use of NIV

研究组 & 干预措施

Non invasive mechanical ventilation

Experimental

The subjects in the immediate intervention group (GI) will be extubated and placed in NIV the moment they enter the recovery room through a portable ventilator (Esprit ® or BiPAP Vision ®, Respironics) in face mask. The parameters will be adjusted as follows: FiO2 = 50%, positive expiratory pressure (EPAP, starting at 4-6 cmH2O and adjusting 1-2 cmH2O to avoid snoring, apnea, paradoxical breathing and desaturations) and adjusted inspiratory positive pressure (IPAP) to maintain a tidal volume of 400 to 500 ml, maintaining IPAP <15cmH2O17. Individuals will receive this ventilatory support for 1 hour. After this period the patients will be submitted to the same care of GP patients.

干预措施: Non invasive mechanical ventilation (Device)

Usual care

Active Comparator

Subjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to the team routine and patient need.

干预措施: GP (Device)

结局指标

主要结局

Forced Vital Capacity (FVC)

时间窗: 1 hour after admission to the recovery room

Larger volume of air mobilized on an exhalation.

Forced expiratory volume in one second (FEV1)

时间窗: 1 hour after admission to the recovery room

Volume of air exhaled in the first second during the FVC maneuver.

FEV1/FVC ratio

时间窗: 1 hour after admission to the recovery room

Ratio between forced expiratory volume in the first second and vital capacity.

Peak expiratory flow (PEF)

时间窗: 1 hour after admission to the recovery room

Maximum air flow during the FVC maneuver.

Forced Vital Capacity (FVC)

时间窗: Preoperative

Larger volume of air mobilized on an exhalation.

Forced Vital Capacity (FVC)

时间窗: 10 minutes after admission to the recovery room

Larger volume of air mobilized on an exhalation.

Forced expiratory volume in one second (FEV1)

时间窗: Preoperative

Volume of air exhaled in the first second during the FVC maneuver.

Forced expiratory volume in one second (FEV1)

时间窗: 10 minutes after admission to the recovery room

Volume of air exhaled in the first second during the FVC maneuver.

FEV1/FVC ratio

时间窗: Preoperative

Ratio between forced expiratory volume in the first second and vital capacity.

FEV1/FVC ratio

时间窗: 10 minutes after admission to the recovery room

Ratio between forced expiratory volume in the first second and vital capacity.

Peak expiratory flow (PEF)

时间窗: Preoperative

Maximum air flow during the FVC maneuver.

Peak expiratory flow (PEF)

时间窗: 10 minutes after admission to the recovery room

Maximum air flow during the FVC maneuver.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验