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

Primary Purpose

Bariatric Surgery Candidate, Obesity, Morbid, Ventilatory Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Non invasive mechanical ventilation
GP
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgery Candidate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients undergoing bariatric surgery

Exclusion Criteria:

  • Absolute or relative contraindications to the use of NIV

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non invasive mechanical ventilation

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Forced Vital Capacity (FVC)
Larger volume of air mobilized on an exhalation.
Forced Vital Capacity (FVC)
Larger volume of air mobilized on an exhalation.
Forced Vital Capacity (FVC)
Larger volume of air mobilized on an exhalation.
Forced expiratory volume in one second (FEV1)
Volume of air exhaled in the first second during the FVC maneuver.
Forced expiratory volume in one second (FEV1)
Volume of air exhaled in the first second during the FVC maneuver.
Forced expiratory volume in one second (FEV1)
Volume of air exhaled in the first second during the FVC maneuver.
FEV1/FVC ratio
Ratio between forced expiratory volume in the first second and vital capacity.
FEV1/FVC ratio
Ratio between forced expiratory volume in the first second and vital capacity.
FEV1/FVC ratio
Ratio between forced expiratory volume in the first second and vital capacity.
Peak expiratory flow (PEF)
Maximum air flow during the FVC maneuver.
Peak expiratory flow (PEF)
Maximum air flow during the FVC maneuver.
Peak expiratory flow (PEF)
Maximum air flow during the FVC maneuver.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2020
Last Updated
March 17, 2021
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04805476
Brief Title
Prophylactic Use of Noninvasive Ventilation in the Postoperative Period of Bariatric Surgery
Official Title
Prophylactic Use of Noninvasive Ventilation in the Postoperative Period of Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Obesity, Morbid, Ventilatory Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non invasive mechanical ventilation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Non invasive mechanical ventilation
Intervention Description
Prophylactic non invasive mechanical ventilation
Intervention Type
Device
Intervention Name(s)
GP
Intervention Description
GP subjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to team routine and patient need.
Primary Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
Larger volume of air mobilized on an exhalation.
Time Frame
Preoperative
Title
Forced Vital Capacity (FVC)
Description
Larger volume of air mobilized on an exhalation.
Time Frame
10 minutes after admission to the recovery room
Title
Forced Vital Capacity (FVC)
Description
Larger volume of air mobilized on an exhalation.
Time Frame
1 hour after admission to the recovery room
Title
Forced expiratory volume in one second (FEV1)
Description
Volume of air exhaled in the first second during the FVC maneuver.
Time Frame
Preoperative
Title
Forced expiratory volume in one second (FEV1)
Description
Volume of air exhaled in the first second during the FVC maneuver.
Time Frame
10 minutes after admission to the recovery room
Title
Forced expiratory volume in one second (FEV1)
Description
Volume of air exhaled in the first second during the FVC maneuver.
Time Frame
1 hour after admission to the recovery room
Title
FEV1/FVC ratio
Description
Ratio between forced expiratory volume in the first second and vital capacity.
Time Frame
Preoperative
Title
FEV1/FVC ratio
Description
Ratio between forced expiratory volume in the first second and vital capacity.
Time Frame
10 minutes after admission to the recovery room
Title
FEV1/FVC ratio
Description
Ratio between forced expiratory volume in the first second and vital capacity.
Time Frame
1 hour after admission to the recovery room
Title
Peak expiratory flow (PEF)
Description
Maximum air flow during the FVC maneuver.
Time Frame
Preoperative
Title
Peak expiratory flow (PEF)
Description
Maximum air flow during the FVC maneuver.
Time Frame
10 minutes after admission to the recovery room
Title
Peak expiratory flow (PEF)
Description
Maximum air flow during the FVC maneuver.
Time Frame
1 hour after admission to the recovery room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients undergoing bariatric surgery Exclusion Criteria: Absolute or relative contraindications to the use of NIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fábio Di Naso, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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