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

NCT04566419 | Completed

• 1 other identifier: 3228
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lung ultrasound; Diaphragmatic ultrasound; High Flow Nasal Cannulae

Outcome Measures

Primary Outcomes (1)

• PaO2/FiO2 ratio

  Change in arterial Pa/FiO2 (in mmHg) in the two groups

  At arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).

Secondary Outcomes (5)

• LUS score

  Preoperative, upon arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).

• Thickening Fraction: Tei - Tee/Tee

  Preoperative, upon arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).

• Respiratory discomfort

  At arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).

• Postoperative Respiratory complications

  At 7 days

• PaO2/FiO2 ratio in hypoxemic patients

  At arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).

Study Arms (2)

Control group

ACTIVE COMPARATOR

Oxygen delivered by Venturi Mask

Other: Oxygen

HFNC - high flow nasal cannulae

EXPERIMENTAL

Oxygen delivered by high flow nasal cannula (HFNC) 60 l/min

Device: HFNC - Airvo 2

Interventions

HFNC - Airvo 2 DEVICE

high flow nasal cannulae delivering 60 l/min

HFNC - high flow nasal cannulae

Oxygen OTHER

oxygen delivered by Venturi mask

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for major gynecologic oncologic surgery (surgery duration \> 2 hours).

You may not qualify if:

• patient's refusal to participate to the study
• pregnancy
• mechanical ventilation in the 2 weeks before surgery
• BMI\>35

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Policlinico Agostino Gemelli

Rome, 00168, Italy

Location

Related Publications (1)

• Frassanito L, Grieco DL, Zanfini BA, Catarci S, Rosa T, Settanni D, Fedele C, Scambia G, Draisci G, Antonelli M. Effect of a pre-emptive 2-hour session of high-flow nasal oxygen on postoperative oxygenation after major gynaecologic surgery: a randomised clinical trial. Br J Anaesth. 2023 Oct;131(4):775-785. doi: 10.1016/j.bja.2023.07.002. Epub 2023 Aug 4.

  PMID: 37543437 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis; Postoperative Complications; Hypoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Luciano Frassanito, MD

  IRCCS Fondazione Policlinico A. Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, randomized (with standard and experimental groups) monocentric study

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 28, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 16, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)