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Completed

NCT Number: NCT04830475

NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Postoperative Respiratory Distress Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Campania Luigi Vanvitelli

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non invasive ventilation (NIV)

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%.

Conventional Venturi Mask

Device

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

Primary outcomes

  1. 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

  2. Blood oxygen saturation (SaPo2)

    Time frame: 12 hours

    the evaluation of the oximetry values of obese patients after postoperative NIV adoption

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Non-invasive Ventilation Prevents Post-operative Respiratory Failure in Patient Undergoing Bariatric Surgery

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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