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poStoperative Anesthesia Care: Facial Mask vs Hfnc and Thoracic Ultrasound for Reduction of Atelectasis Incidence

NCT04566419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-09-16

No results posted yet for this study

Summary

The primary aim of this study is to assess the efficacy of post-operatory HFNC in reducing the incidence of hypoxemia after gynecological oncology surgery, compared to the standard application of O2 through a Venturi mask; The secondary objectives are to investigate the occurrence and entity of lung atelectasis, to evaluate diaphragmatic function and respiratory discomfort, and to evaluate the incidence of respiratory complications after seven days in the two groups.

Patients will be randomized into two groups: HFNC and Control. The patients will be studied with preoperative lung and diaphragmatic ultrasound. Standard general anesthesia will be administered in the two groups. Ultrasound will be performed at arrival in the recovery room (RR) and before discharge from the RR. In the HFNC group, high-flow O2 will be administered; in the control group standard O2 therapy with Venturi mask will be administered.

Arterial blood gas analysis upon arrival in the RR and after two hours of O2 therapy in both groups will be checked.

The incidence of post-operative respiratory complications will be monitored in the seven days following surgery.

Conditions

  • Pulmonary Atelectasis
  • Postoperative Complications
  • Gynecologic Cancer
  • Anesthesia
  • Hypoxemia

Interventions

DEVICE

HFNC - Airvo 2

high flow nasal cannulae delivering 60 l/min

OTHER

Oxygen

oxygen delivered by Venturi mask

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Luciano Frassanito, MD · IRCCS Fondazione Policlinico A. Gemelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-06-01
Completion
2022-06-01

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 NCT04566419 on ClinicalTrials.gov