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Preoxygenation Before General Anesthesia

NCT03802643 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2019-01-14

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Parma

    lead OTHER

Principal Investigators

  • Michela Tosi, MD · Azienda Ospedaliero-Universitaria di Parma

  • Benedetta Siroli, MD · University of Parma

  • Samantha Gorgoglione, MD · University of Parma

  • Valentina Bellini, MD · University of Parma

  • Leonardo Fortunati, MD · University of Parma

  • Andrea Parodi, MD · University of Parma

  • Andrea Briolini, MD · University of Parma

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2019-12-20
Completion
2020-01-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03802643 on ClinicalTrials.gov