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

NCT04805476 | Completed DMC

• 1 other identifier: 50468415.1.0000.5327
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Obesity, Morbid; Ventilatory Failure

Outcome Measures

Primary Outcomes (12)

• Forced Vital Capacity (FVC)

  Larger volume of air mobilized on an exhalation.

  Preoperative

• Forced Vital Capacity (FVC)

  Larger volume of air mobilized on an exhalation.

  10 minutes after admission to the recovery room

• Forced Vital Capacity (FVC)

  Larger volume of air mobilized on an exhalation.

  1 hour after admission to the recovery room

• Forced expiratory volume in one second (FEV1)

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

  Preoperative

• Forced expiratory volume in one second (FEV1)

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

  10 minutes after admission to the recovery room

• Forced expiratory volume in one second (FEV1)

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

  1 hour after admission to the recovery room

• FEV1/FVC ratio

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

  Preoperative

• FEV1/FVC ratio

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

  10 minutes after admission to the recovery room

• FEV1/FVC ratio

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

  1 hour after admission to the recovery room

• Peak expiratory flow (PEF)

  Maximum air flow during the FVC maneuver.

  Preoperative

• Peak expiratory flow (PEF)

  Maximum air flow during the FVC maneuver.

  10 minutes after admission to the recovery room

• Peak expiratory flow (PEF)

  Maximum air flow during the FVC maneuver.

  1 hour after admission to the recovery room

Study Arms (2)

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.

Device: Non invasive mechanical ventilation

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.

Device: GP

Interventions

Non invasive mechanical ventilation DEVICE

Prophylactic non invasive mechanical ventilation

Non invasive mechanical ventilation

GP DEVICE

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.

Usual care

Eligibility Criteria

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

You may qualify if:

• Adult patients undergoing bariatric surgery

You may not qualify if:

• Absolute or relative contraindications to the use of NIV

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Obesity, Morbid; Hypoventilation

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Fábio Di Naso, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: March 18, 2021
• Study Start: March 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: July 31, 2018
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)