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Preoxygenation Before General Anesthesia (PREOX2018)

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ClinicalTrials.gov Identifier: NCT03802643
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Elena Giovanna Bignami, University of Parma

Tracking Information
First Submitted Date January 3, 2019
First Posted Date January 14, 2019
Last Update Posted Date January 14, 2019
Actual Study Start Date December 20, 2018
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 9, 2019)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Preoxygenation Before General Anesthesia
Official Title Assessment of Oxygenation Values Before General Anesthesia in Elective Surgery
Brief 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.

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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Week
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Non-critically ill patients (with no high risk of desaturation) undergoing general anesthesia before elective surgery.
Condition
  • Anesthesia
  • Preoxygenation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 9, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 20, 2020
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Elena Giovanna Bignami, Professor of Anesthesiology +390521033609 elenagiovanna.bignami@unipr.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03802643
Other Study ID Numbers 530/2018/OSS/AOUPR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Elena Giovanna Bignami, University of Parma
Study Sponsor University of Parma
Collaborators Not Provided
Investigators
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
PRS Account University of Parma
Verification Date January 2019