Preoxygenation Before General Anesthesia (PREOX2018)

January 9, 2019 updated by: Elena Giovanna Bignami, University of Parma

Assessment of Oxygenation Values Before General Anesthesia in Elective Surgery

Rationale of the study: we aim to clarify the question (related to still unclear and not univocal response) about the protective or unnecessary role of preoxygenation in non-critically ill patients (otherwise with no high risk of desaturation) undergoing general anesthesia before elective surgery.

It will be also necessary differentiate the development of postoperative complications (pulmonary, cardiovascular, neurological, surgical) due to preoxygenation from the ones related with patient comorbidity, intraoperative and surgical causes, tube disconnection.

Procedure: patient's informed consent signature for adhesion at the study will be initially requested. With their acceptance, parameters will be recorded anonymously in the Case Report Form, identified by their initials and an alphanumeric code, until hospital discharge.

The parameters analyzed will be related to:

  • preoperative evaluation; about anamnesis, health general conditions, blood oxygen saturation (Sat02), Metabolic Equivalent of Task (METs)
  • intraoperative evaluation; about oxygenations values, recorded before/during induction and maintenance of general anesthesia
  • postoperative evaluation; about postoperative complications, pulmonary primarily, and secondary cardiovascular, neurological and surgical, based on the medical record.

The data wil be transferred on Excel worksheet, utilized for descriptive analysis related at every variable. By multivariate logistic regression will be evaluated the major factors influencing postoperative pulmonary complications (PPCs) onset in patients undergoing preoxygenation for elective surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Background of the study:

Preoxygenation is a widely used technique that improves the safety of endotracheal intubation. The procedure is carried out by supplying 100% oxygen (FiO2 of 1.0) before the induction of general anesthesia until both end-tidal oxygen (EtO2)>90% and end-tidal N2 (EtN2)<5% are reached. Both these markers define the efficacy of the procedure. As a result, the lung oxygen content is increased far beyond normal oxygen consumption by saturating the functional residual capacity with 100% oxygen. This allows for a longer safe apnea time (i.e. the time required for oxyhemoglobin saturation to drop below 90%). The rate at which oxyhemoglobin saturation drops during apnea indicates the efficiency of the maneuver.

This procedure is strongly recommended for all patients undergoing general anesthesia since it lengthens safe laryngoscopy time and grants a wider timeframe to respond to a "cannot intubate/cannot oxygenate" (CICO) scenario, a rare yet life threatening situation. It remains unclear whether this should be considered mandatory for non-critically ill and non-obese patients since their oxygen reserves should suffice for the time required to perform endotracheal intubation or regain spontaneous breathing in the event of a CICO scenario. Nonetheless, the guidelines for the management of endotracheal intubation, proposed by the Difficult Airway Society in 2015 United Kingdom state how it is pivotal to preoxygenate every patient before attempting to intubate. Several methods of preoxygenation have been validated and compared according to duration of safe apnea time, duration of the procedure, success rate (defined as "avoiding manual re-ventilation"), and patient tolerance. The choice between these techniques is based on patient characteristics (age, sex, Body Mass Index, American Society of Anesthesiologist score, Cormack-Lehane grade and Glasgow Coma Scale), settings (e.g., operating room, Intensive Care Unit, emergency situations), equipment, and anesthesiologist's preferences. The two standard approaches are six deep breaths in 1 min and tidal volume breathing for three to 5 min, both at 100% inspired oxygen via a face mask.

The main side effect of preoxygenation is absorption atelectasis that occurs when delivering 100% inspired oxygen. This can be avoided using a lower inspired oxygen concentration (90%), positive pressure techniques, and/or recruitment maneuvers post-endotracheal intubation. Due to the short duration of the procedure, the production of reactive oxygen species and cardiovascular responses are minimal and should not prevent routine preoxygenation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Parma
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-critically ill patients (with no high risk of desaturation) undergoing general anesthesia before elective surgery.

Description

Inclusion Criteria:

  • informed consent signature
  • eligible for preoxygenation before general anesthesia, in elective surgery
  • age > 18 years
  • surgery duration > 30 min

Exclusion Criteria:

  • emergency/urgent surgery
  • severe respiratory disease: Chronic Obstructive Pulmonary Disease stages III-IV, pulmonary fibrosis, documented bullous emphysema, severe emphysema, pneumothorax
  • uncontrolled asthma
  • severe cardiac disease: Heart Failure stages III-IV (New York Heart Association), coronary artery disease stages III-IV (Canadian Cardiovascular Society)
  • previous thoracic surgery
  • pregnancy (excluded by anamnesis or laboratory test)
  • informed consent refusal

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of preoxygenation use in elective surgery, reporting oxygenations values
Time Frame: From before induction of general anesthesia until the end of surgical procedure, up to 10 hours
Assessment of its efficacy and efficiency in non-critically ill patients, reporting blood oxygen levels just before induction, during induction and maintenance of general anesthesia
From before induction of general anesthesia until the end of surgical procedure, up to 10 hours
Incidence of postoperative pulmonary complications (PPC) related to preoxygenation
Time Frame: From immediately after surgery until hospital discharge, up to 26 weeks
Differentiating PPCs due to preoxygenation from the ones related with patient comorbidity, intraoperative and surgical causes, tube disconnection
From immediately after surgery until hospital discharge, up to 26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of intraoperative desaturation/hypoxia
Time Frame: From achieved endotracheal intubation until the end of surgical procedure, up to 10 hours
From achieved endotracheal intubation until the end of surgical procedure, up to 10 hours
Incidence of cardiovascular postoperative complications
Time Frame: From immediately after surgery until hospital discharge, up to 26 weeks
From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of neurological postoperative complications
Time Frame: From immediately after surgery until hospital discharge, up to 26 weeks
From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of surgical postoperative complications
Time Frame: From immediately after surgery until hospital discharge, up to 26 weeks
From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of Intensive Care Unit admission and its duration
Time Frame: From immediately after surgery until hospital discharge, up to 26 weeks
From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of length of in-hospital stay
Time Frame: From immediately after surgery until hospital discharge, up to 26 weeks
From immediately after surgery until hospital discharge, up to 26 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Parma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michela Tosi, MD, Azienda Ospedaliero-Universitaria di Parma
  • Principal Investigator: Benedetta Siroli, MD, University of Parma
  • Principal Investigator: Samantha Gorgoglione, MD, University of Parma
  • Principal Investigator: Valentina Bellini, MD, University of Parma
  • Principal Investigator: Leonardo Fortunati, MD, University of Parma
  • Principal Investigator: Andrea Parodi, MD, University of Parma
  • Principal Investigator: Andrea Briolini, MD, University of Parma

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 530/2018/OSS/AOUPR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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