Non Invasive Ventilation Combined to High Flow Nasal Cannula Oxygen for Preoxygenation of Hypoxemic ICU Patients (OPTINIV)

April 6, 2017 updated by: University Hospital, Montpellier

Comparison of Two Methods of Preoxygenation Before Oro Tracheal Intubation in the Hypoxemic Patient in Intensive Care Unit : Non Invasive Ventilation (NIV) + High Flow Nasal Cannula Oxygen Versus NIV Alone : a Randomized Controlled Study

Tracheal intubation is a challenging procedure in Intensive Care Unit (ICU), associated with severe life threatening complications. To decrease these complications, preoxygenation is recommended. Non invasive ventilation (NIV) increase effectiveness of preoxygenation, applying a positive end expiratory pressure (PEEP). High-flow nasal cannula oxygen (HFNC) improves oxygenation by increasing end-expiratory lung volume and has a potential of apneic oxygenation. The association of NIV and HFNC for preoxygenation in hypoxemic ICU patients has never been evaluated. The aim of this study is to determine if HFNC combined to NIV could have therapeutic advantages over NIV alone for preoxygenation in the ICU patients intubated for hypoxemic acute respiratory failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients admitted in Intensive Care Unit (ICU) often need respiratory support. Endotracheal intubation procedure in ICU is associated with severe life threatening complications. In order to decrease the incidence of complications including hypoxemia during intubation procedure, a preoxygenation is recommended, consisting in the administration of pure oxygen before intubation.

Recent data suggest that NIV use for preoxygenation of patients with acute respiratory failure is associated with less hypoxemia during intubation procedure than classic preoxygenation with facial mask. Indeed, associating Pressure Support (PS) with Positive end expiratory pressure (PEEP) limits the alveolar collapse and atelectasis formation. NIV is now used by a lot of of teams for preoxygenation of patients with acute respiratory failure in ICU.

However, although NIV is effective to reduce hypoxemia during intubation procedure, NIV mask has to be taken off after preoxygenation in order to allow the passage of the oro tracheal tube through the mouth. The hypoxemic patient does not receive oxygen during this period, which participates to the episodes of major hypoxemia during intubation.

In contrast, HFNC, which delivers high flow heated and humidified oxygen and air via nasal prongs at a prescribed fraction of inspired oxygen and a maximum flow of 60 L/min can be pursued during the intubation procedure. Some very recent studies suggest that HNFC could allow apneic oxygenation.

Although use of HFNC combined to NIV may have potential advantages over conventional NIV for preoxygenation before intubation in hypoxemic ICU patients, this technique of preoxygenation has never been assessed and benefit remains to be established.

The OPTINIV study aims to compare the effects of preoxygenation with combination of NIV and HFNC versus NIV alone on lowest oxygen saturation during intubation procedure of ICU patients intubated for acute respiratory failure.

Study design and population The OPTINIV trial is an investigator initiated multicenter randomized controlled two-arm blinded trial.

Local investigators screen consecutive patients intubated in ICU, with an acute respiratory failure (respiratory rate > 25/min) and hypoxemia. Hypoxemia is defined by the need of a fraction inspirated in oxygen (FiO2)>50% to maintain a saturation of arterial blood with oxygen as measured by pulse oximetry (SpO2)>90% and a partial pressure of oxygen in the arterial blood (PaO2)/FiO2 ratio<300 mmHg under mask oxygen therapy with a flow of 15L/min (measured during the 4 hours before inclusion).

Patients fulfilling one or more of the following criteria will not be included: nonadult patients (age <18 years), pregnant, protected persons, intubation in case of cardio circulatory arrest, nasopharyngeal obstacle contraindicating the use of HNFC.

Ethics and consent The Institutional Review Board of the University Hospital of Montpellier (France) approved the trial. By May 2015, the study had been approved by a central ethics committee (Committee for the Protection of Persons, Montpellier, France) with the registration number IDRCB 2015-A00708-41.

All patients or their next will asked for signed informed consent, as required by the institutional review board in accordance with the Declaration of Helsinki or emergency procedure allowed inclusion as a part of care in acute situation according the French Law.

Data collection The following data will be collected and registered before intubation: demographic data : age, sex, weight, height, date and hour of intubation, severity scores (Simplified Acute Physiologic Score (SAPS) II at admission, Sequential Organ Failure Assessment (SOFA) score on the day of the procedure), type of admission, reason of admission in ICU, indication of intubation, comorbidities, nature and number of operators, formation, fluid loading before intubation, arterial pressure and lowest saturation, therapeutic by vasopressor drugs or non invasive ventilation, predictive criteria of difficult intubation (including the MACOCHA score).

During the preoxygenation, will be recorded : need to change the method of preoxygenation and the reasons for changing, size of intubation tube, vital parameters : oxygen saturation at the beginning and at the end of the preoxygenation, lowest saturation, lowest and highest arterial pressure and heart rate, length and difficulty of preoxygenation.

During the intubation procedure, the following parameters will be collected : hypnotic and neuromuscular blocker used and dose, oxygen saturation at the beginning and at the end, lowest saturation, total length of intubation procedure, difficult intubation, number of operators, number of attempts, Cormack grade, traction force on the laryngoscope, Sellick manoeuver, occurrence of complications related to intubation.

After the intubation procedure (until one hour after): a thorax X-ray will be done, and arterial blood gases. Complications related to intubation will be collected.

Length of mechanical ventilation, length of stay in ICU, mortality at day 28 will be recorded.

Trial interventions Patients eligible for inclusion are randomly assigned to the interventional group or to the reference group. In the interventional group, a preoxygenation by NIV (PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100%) combined to HNFC (Flow of 60L/min, FiO2 = 100%) is applied. HFNC will applied along all the intubation procedure including the apnea period. In the reference group, a preoxygenation by NIV only (PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100%) will be applied.

Outcomes Primary outcome variable is the lowest oxygen saturation collected by pulse oxymetry during the intubation procedure. The intubation procedure lasts from the beginning of the first laryngoscopy to the confirmation of the orotracheal intubation.

Secondary outcome variables are preoxygenation quality, complications related to intubation (severe : severe hypoxemia defined by lowest saturation < 80 %, severe cardiovascular collapse, defined as systolic blood pressure less than 65 mm Hg recorded at least one time or less than 90 mm Hg that lasted 30 minutes despite 500-1,000 ml of fluid loading (crystalloids or colloids solutions) or requiring introduction of vasoactive support, cardiac arrest, death during intubation; moderate: difficult intubation, arrhythmias, esophageal intubations, agitation, pulmonary aspiration, dental injuries), morbidity in ICU (length of stay, length of mechanical ventilation, mortality at 28 days).

Statistical analysis Quantitative variables will be expressed as means (standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or the Wilcoxon test as appropriate (Gaussian or non Gaussian variables). Qualitative variables will be compared using the chi 2 test or the Fisher test as appropriate.

A linear regression will be used to adjust the relation of lowest oxygen saturation during intubation procedure and group of inclusion. A multivariate model will be established.

A p-value of ≤ .05 will be considered statistically significant. The statistical analysis will be performed by the medical statistical department of the Montpellier University Hospital with the help of statistical software (SAS, version 9.3; SAS Institute; Cary, NC and R, version 2.14.1).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Centre Hospitalier Universitaire Montpellier, Saint Eloi

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult hypoxemic patients
  • Patients intubated in the ICU for acute respiratory failure (Hypoxemia is defined by the need of a FiO2>50% to maintain a SpO2>90% and a PaO2/FiO2 ratio<300 mmHg under mask oxygen therapy with a flow of 15L/min (measured during the 4 hours before inclusion)).

Exclusion Criteria:

  • non adult patients (age <18 years)
  • pregnant woman
  • protected persons
  • Patient intubated in case of cardio circulatory arrest
  • Patient with nasopharyngeal obstacle contraindicating the use of HNFC

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
In the interventional group, a preoxygenation by NIV (PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100%) combined to HNFC (Flow of 60L/min, FiO2 = 100%) is applied.
Device: Non invasive ventilation + High flow nasal cannula oxygen
In the interventional group, a preoxygenation by NIV (venturi mask of Intersurgical or Respironics mask) with PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100% and combined to HNFC (nasal cannula oxygen of Fisher and Paykel) with Flow of 60L/min, FiO2 = 100% is applied.
Other: Reference
In the reference group, a preoxygenation by NIV only (PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100%) is applied.
Device: Non invasive ventilation
In the reference group, a preoxygenation by NIV (venturi mask of Intersurgical or Respironics mask) only, with PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100% is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lowest oxygen saturation
Time Frame: 1 years
1 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of complications related to intubation
Time Frame: 1 years
1 years

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Samir JABER, M.D, Ph.D, Departement of Unit Care in Montpellier

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 (Actual)

June 23, 2015

Primary Completion (Actual)

February 28, 2016

Study Completion (Actual)

March 17, 2016

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9543 (Other Identifier: CTEP)
  • 2015-A00708-41 (Other Identifier: RCB number)

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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