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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01887015
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Hypoxemia Device: Nasal high flow cannula (OptiflowTM, MR850 heated humidified, Fisher & Paykel Healthcare, Auckland, New Zealand) Phase 4

Detailed Description:

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Early Nasal High Flow Oxygen Therapy for Prevention of Postoperative Hypoxemia After Abdominal Surgery: A Multicenter Randomized Controlled Trial
Study Start Date : June 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Standard oxygen therapy
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).
 Device: Nasal high flow cannula (OptiflowTM, MR850 heated humidified, Fisher & Paykel Healthcare, Auckland, New Zealand)
Other Name: Nasal high flow oxygen therapy versus standard oxygen therapy
nasal high flow oxygen therapy
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).
 Device: Nasal high flow cannula (OptiflowTM, MR850 heated humidified, Fisher & Paykel Healthcare, Auckland, New Zealand)
Other Name: Nasal high flow oxygen therapy versus standard oxygen therapy


Outcome Measures
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Primary Outcome Measures :
  1. percentage of patients who developed postoperative hypoxemia (defined as PaO2/FiO2 ratio <300) [ Time Frame: 1 hour after tracheal extubation (day 1) ]

Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887015


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Emmanuel FUTIER, MD, Ph D University Hospital, Clermont-Ferrand
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01887015    
Other Study ID Numbers: CHU-0157
2013-A00030-45
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015
Keywords provided by University Hospital, Clermont-Ferrand:
Postoperative pulmonary complications
Oxygen therapy
Nasal high flow oxygen therapy
Nasal high flow cannula
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory