CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE). +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05550584
NCT05550584N/ACompleted

High Flow Oxygen During ProcEdural Sedation for Operative Hysteroscopy: a Randomized Controlled Trial - HOPE Study.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·interventional·Posted Sep 22, 2022·Updated Sep 5, 2024

In Brief

A clinical study evaluating Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE). and LMA for Endometrium; Hypertrophy, Cervix and 2 related conditions. Completed, enrolled 180 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 22, 2022
Enrollment StartJun 17, 2022
Primary CompletionOct 1, 2022
Study CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.8 years ago

Interventions

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE).device

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.

LMAdevice

Mechanical ventilation performed by a laringeal mask