NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

NCT ID: NCT04830475

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-02-20

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.

Conditions

Obesity; Postoperative Respiratory Distress

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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%.

Group Type: EXPERIMENTAL

Non invasive ventilation (NIV)

Intervention Type: DEVICE

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%.

Control Group

In the postoperative period, patients were offered VenturiMask with Fio2 60% at 15 l / m.

Group Type: ACTIVE_COMPARATOR

Conventional Venturi Mask

Intervention Type: DEVICE

Patients were offered VenturiMask with Fio2 60% at 15 l / m.

Interventions

Non invasive ventilation (NIV)

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 Type: DEVICE

Conventional Venturi Mask

Patients were offered VenturiMask with Fio2 60% at 15 l / m.

Intervention Type: DEVICE

Eligibility Criteria

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
• Asthma
• Severe renal dysfunction,
• cardiac disease resulting in marked limitation of physical activity, corresponding to NYHA class >II

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Claudio Gambardella

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Campania Luigi Vanvitelli

Napoli, , Italy

Countries

Italy

Other Identifiers

NIV in obese

Identifier Type: -

Identifier Source: org_study_id