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Completed

NCT Number: NCT01887015

Optiflow® to Prevent Post-Extubation Hypoxemia afteR Abdominal Surgery (the OPERA Trial)

To evaluate whether early application of nasal high flow oxygen therapy after extubation can reduce the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

Postoperative hypoxemia complicates between 30 to 50% of patients after abdominal surgery. Loss of functioning alveolar units and development of atelectasis after abdominal surgery have been recognized as the underlying mechanisms responsible for postoperative hypoxemia. Supplemental Oxygen administration is therefore widely recommended after extubation in the postoperative period, especially in patients with high risk of postoperative respiratory complications. Although oxygen therapy is effective in preventing the vast majority of severe postoperative hypoxemia after extubation in surgical patients, respiratory failure may occur, thus requiring endotracheal intubation and mechanical ventilation or therapeutic use of non-invasive positive pressure ventilation (NPPV). In patients with postoperative hypoxemia (defined as patients with a PaO2/FiO2 ratio <300), application of NPPV was found to decrease the incidence of endotracheal intubation after abdominal surgery. Nevertheless, use of NPPV in the postoperative period is responsible for organizational constraints and increases healthcare utilization.

Nasal high flow cannula (NHFC) has been described as an attractive and well-tolerated method of non-invasive oxygen delivery. Previous studies have shown that NHFC generates a low level of positive airway pressure, increases end-expiratory lung volume and reduces airway resistance, thus contributing to a reduction in work of breathing. To date, however, no clinical trials have compared NHFC to standard oxygen therapy in the prevention of postoperative hypoxemia after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications.

The primary objective of the study is to compare: 1- Standard oxygen therapy; 2- Nasal high flow oxygen therapy after extubation in patients with intermediate to high risk of postoperative pulmonary complications after abdominal surgery.

Our hypothesis is that, compared with standard oxygen therapy, early application of nasal high flow oxygen therapy can reduce the need for postoperative NPPV for postoperative hypoxemia (defined as PaO2/FiO2 ratio <300).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Planned or unplanned surgical procedures
  • Abdominal or abdominal and thoracic surgery
  • Expected duration ≥2 hours
  • ARISCAT score ≥26 points

Exclusion criteria

  • Age <18 years
  • Body mass index >35 kg/m2
  • Sleep apnea syndrome
  • Patient refusal
  • Pregnancy and/or lactation

Treatment and study plan

Nasal high flow cannula (OptiflowTM, MR850 heated humidified, Fisher & Paykel Healthcare, Auckland, New Zealand)

Device

Other names: Nasal high flow oxygen therapy versus standard oxygen therapy

Primary outcomes

  1. percentage of patients who developed postoperative hypoxemia (defined as PaO2/FiO2 ratio <300)

    Time frame: 1 hour after tracheal extubation (day 1)

Secondary outcomes

  1. Postoperative gas exchange (PaO2, PaCO2)

    Time frame: 1H after extubation and after surgery (at day 1)

  2. Need for supplemental oxygen therapy beyond postoperative day 1 (defined as arterial oxygen saturation by pulse oximetry (SpO2) <93% in room air)

    Time frame: at day 1

  3. Need for endotracheal intubation or non-invasive ventilation for postoperative acute respiratory failure (ARF)

    Time frame: within the first 7 days after surgery

    ARF (acute respiratory failure) is defined by one of the hypoxemic criteria (SpO2 <92% while breathing at least 10 L/min oxygen, PaO2 <60 mmHg on air or <80 mmHg while breathing any supplemental oxygen) and at least 1 of the following criteria: severe respiratory distress with dyspnea, accessory muscle recruitment and paradoxical abdominal or thoracic motion, respiratory rate >25 breaths/min, respiratory acidosis with pH <7.30 and PaCO2 > 50 mmHg.

  4. Postoperative pulmonary complications (PPCs)

    Time frame: within the first 7 days after surgery

    PPCs(Postoperative pulmonary complications ) are scored using a grade scale ranging from 0 to 4, with grade 0 representing the absence of any complications and grade 1 through 4 representing successively the worse forms of complications.

  5. Respiratory discomfort using a numerical rating scale (NRS) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort).

    Time frame: within the first 7 days after surgery

    Discomfort symptoms are assessed by evaluating dryness of the nose, mouth and throat.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Early Nasal High Flow Oxygen Therapy for Prevention of Postoperative Hypoxemia After Abdominal Surgery: A Multicenter Randomized Controlled Trial

Acronym: OPERA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2013
Registry last updated
Mar 27, 2015

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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