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High Flow Oxygen During Operative Hysteroscopy.

NCT05550584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-09-05

No results posted yet for this study

Summary

High-flow nasal cannula (HFNC) oxygen therapy represents an open circuit ventilation system that uses flows up to 70 L/min of 100% oxygen through the Optiflow THRIVETM device (Fisher and Paykel Healthcare Ltd, Auckland, New Zealand). Compared to conventional oxygen therapy systems, the heating and humidification of the flows facilitate tolerability by the patient, allow to reach higher and more stable inspiratory fractions of oxygen, produce a flow-dependent effect of continuous positive airway pressure and by reducing dead space, have the potential to increase alveolar volume and improve gas exchanges.

The use of HFNC is increased in anesthesia as the only airways management technique during short-term procedures under procedural sedation or general anesthesia.

Operative hysteroscopy is a short-term procedure (\<30 minutes), usually performed in a day-hospital regimen, under procedural sedation. In case of apnea and/or hypoventilation, or for long and complex hysteroscopic procedures, the patient can be ventilated through facial or laryngeal masks.

The primary objective of this prospective randomized controlled trial is to compare the rate of success of ventilation using the THRIVE device to laryngeal mask ventilation during operative hysteroscopies under procedural sedation.

Secondary objectives will be the comparison of the percentage of complications in terms of inability to manage the airways, episodes of hypotension, cardiac arrhythmias, post-operative nausea and vomiting, degree of dyspnea and comfort of the patient in the Post-Anesthesia Care Unit between the two methods.

Conditions

  • Endometrium; Hypertrophy, Cervix
  • Anesthesia
  • Apnea, Postanesthetic

Interventions

DEVICE

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE).

In the THRIVE group, dedicated Optiflow THRIVE nasal cannulas will be positioned for 100% high flow oxygen therapy at an initial flow of 30 L/min. After induction of anesthesia and throughout the procedure the flow of oxygen will be increased to 70 L/min.

DEVICE

LMA

Mechanical ventilation performed by a laringeal mask

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-17
Primary Completion
2022-10-01
Completion
2023-05-01

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 NCT05550584 on ClinicalTrials.gov