AnesthesiaPREOX2018NCT03802643
Preoxygenation Before General Anesthesia
An observational study of Anesthesia and Preoxygenation, run by University of Parma at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Preoxygenation
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2018to 20 Jan 2020
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-critically ill patients (with no high risk of desaturation) undergoing general anesthesia before elective surgery.
Who may be able to join
- informed consent signature
- eligible for preoxygenation before general anesthesia, in elective surgery
- age > 18 years
- surgery duration > 30 min
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Elena Giovanna Bignami, Professor of Anesthesiology contact
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
Elena Giovanna Bignami, MD Professor, +390521033609, elenagiovanna.bignami@unipr.it
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Anesthesia, Preoxygenation
- Keywords
- Oximetry, Desaturation of Blood, Postoperative pulmonary complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of preoxygenation use in elective surgery, reporting oxygenations values
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
Measured: 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
Differentiating PPCs due to preoxygenation from the ones related with patient comorbidity, intraoperative and surgical causes, tube disconnection
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Secondary outcomes (6)
Incidence of intraoperative desaturation/hypoxia
Measured: From achieved endotracheal intubation until the end of surgical procedure, up to 10 hours
Incidence of cardiovascular postoperative complications
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of neurological postoperative complications
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of surgical postoperative complications
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of Intensive Care Unit admission and its duration
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of length of in-hospital stay
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start20 Dec 2018
- Primary completion20 Dec 2019 (estimated)
- Study completion20 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Giovanna Bignami, University of Parma
- Investigators
- Michela Tosi, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaBenedetta Siroli, MD, Principal investigator, University of ParmaSamantha Gorgoglione, MD, Principal investigator, University of ParmaValentina Bellini, MD, Principal investigator, University of ParmaLeonardo Fortunati, MD, Principal investigator, University of ParmaAndrea Parodi, MD, Principal investigator, University of ParmaAndrea Briolini, MD, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802643
- Sponsor's protocol ID
- 530/2018/OSS/AOUPR
- Acronym
- PREOX2018
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oxygenation Values Before General Anesthesia in Elective Surgery
- ClinicalTrials.gov ID
- NCT03802643
- Acronym / sponsor ID
- PREOX2018 / 530/2018/OSS/AOUPR
- Conditions
- Anesthesia, Preoxygenation
- Keywords
- Oximetry, Desaturation of Blood, Postoperative pulmonary complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 20 Jan 2020 (estimated)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-critically ill patients (with no high risk of desaturation) undergoing general anesthesia before elective surgery.
Key inclusion criteria (4 listed)
- informed consent signature
- eligible for preoxygenation before general anesthesia, in elective surgery
- age > 18 years
- surgery duration > 30 min
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
6 secondary outcomes
Incidence of intraoperative desaturation/hypoxia
Time frame: 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
Incidence of neurological postoperative complications
Time frame: 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
Incidence of Intensive Care Unit admission and its duration
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Giovanna Bignami, Professor of Anesthesiology contact
Michela Tosi, MD principal investigator
Azienda Ospedaliero-Universitaria di Parma
Benedetta Siroli, MD principal investigator
University of Parma
Samantha Gorgoglione, MD principal investigator
University of Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Preoxygenation, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Giovanna Bignami, Professor of Anesthesiology (+390521033609, elenagiovanna.bignami@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019; AzTrials last refreshed its copy on 27 Oct 2026.