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

March 26, 2015 updated by: University Hospital, Clermont-Ferrand

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Nasal high flow oxygen therapy versus standard oxygen therapy
OTHER: 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 Names:
  • Nasal high flow oxygen therapy versus standard oxygen therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative gas exchange (PaO2, PaCO2)
Time Frame: 1H after extubation and after surgery (at day 1)
1H after extubation and after surgery (at day 1)
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
at day 1
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.
within the first 7 days after surgery
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.
within the first 7 days after surgery
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.
within the first 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Emmanuel FUTIER, MD, Ph D, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (ESTIMATE)

June 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0157
  • 2013-A00030-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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