Preoxygenation Before General Anesthesia

NCT03802643 | Unknown

• 1 other identifier: 530/2018/OSS/AOUPR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia; Preoxygenation

Keywords

Oximetry; Desaturation of Blood; Postoperative pulmonary complications

Outcome Measures

Primary Outcomes (2)

• 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

  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

  From immediately after surgery until hospital discharge, up to 26 weeks

Secondary Outcomes (6)

• Incidence of intraoperative desaturation/hypoxia

  From achieved endotracheal intubation until the end of surgical procedure, up to 10 hours

• Incidence of cardiovascular postoperative complications

  From immediately after surgery until hospital discharge, up to 26 weeks

• Incidence of neurological postoperative complications

  From immediately after surgery until hospital discharge, up to 26 weeks

• Incidence of surgical postoperative complications

  From immediately after surgery until hospital discharge, up to 26 weeks

• Incidence of Intensive Care Unit admission and its duration

  From immediately after surgery until hospital discharge, up to 26 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Giovanna Bignami, Professor of Anesthesiology

CONTACT

+390521033609; elenagiovanna.bignami@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 14, 2019
• Study Start: December 20, 2018
• Primary Completion: December 20, 2019
• Study Completion: January 20, 2020
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

IT (1)