Non-invasive Ventilation Prevents Post-operative Respiratory Failure in Patient Undergoing Bariatric Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Intensive care unit admission rate
Study Overview
Brief Summary
Postoperative non-invasive ventilation (NIV) has been proposed as an attractive strategy to reduce morbidity and improve postoperative outcomes in obese subjects undergoing general anesthesia. Bariatric patients present a peculiar negative feature; the increased body mass index (BMI) correlates with loss of perioperative functional residual capacity (FRC), expiratory reserve volume (ERV) and total lung capacity (TLC), decreased up to 50% of preoperative values. The aim of the current randomized trial is to evaluate the efficacy of NIV in post-anaesthesia care unit (PACU) in reducing post-extubation acute respiratory failure and the consequent admission in intensive care units (ICU) after BIBP in obese adult patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Morbid Obesity
- •Patients undergoing Biliointestinal Bypass (BIBP)
Exclusion Criteria
- •Patients requiring emergency operation with rapid sequence induction
- •Patients with suspected presence of difficult airway or pre-existing lung impairment
- •Pregnancy
- •Severe renal dysfunction,
- •cardiac disease resulting in marked limitation of physical activity, corresponding to NYHA class >II
Arms & Interventions
NIV Group
In poostoperative period, patients allocated in NIV Group fulfilled a 120-minute cycle of PSV + PEEP with full-face mask. Ventilation was performed with a Draeger Ventilator with the following basic settings: DeltaPInsp 10 mmHg + PEEP 5 mmHg + Fio2 60%.
Intervention: Non invasive ventilation (NIV) (Device)
Control Group
In the postoperative period, patients were offered VenturiMask with Fio2 60% at 15 l / m.
Intervention: Conventional Venturi Mask (Device)
Outcomes
Primary Outcomes
Intensive care unit admission rate
Time Frame: 72 hours
The primary outcome was the evaluation of the ICU admission rate after NIV in postoperative management of obese patients
Blood oxygen saturation (SaPo2)
Time Frame: 12 hours
the evaluation of the oximetry values of obese patients after postoperative NIV adoption
Secondary Outcomes
No secondary outcomes reported
Investigators
Claudio Gambardella
Clinical Professor
University of Campania "Luigi Vanvitelli"