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

NCT ID: NCT01887015

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-03-31

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.

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).

Conditions

Postoperative Hypoxemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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).

Group Type: OTHER

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Nasal high flow oxygen therapy versus standard oxygen therapy

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel FUTIER, MD, Ph D

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

References

Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.

Reference Type: DERIVED

PMID: 27771739 (View on PubMed)

Futier E, Paugam-Burtz C, Constantin JM, Pereira B, Jaber S. The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial. Trials. 2013 Oct 18;14:341. doi: 10.1186/1745-6215-14-341.

Reference Type: DERIVED

PMID: 24138710 (View on PubMed)

Other Identifiers

2013-A00030-45

Identifier Type: -

Identifier Source: secondary_id

CHU-0157

Identifier Type: -

Identifier Source: org_study_id