High Flow Oxygen During Operative Hysteroscopy.

NCT05550584 | Completed

• 1 other identifier: 4872
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

High flow nasal cannula Oxygen; Procedural sedation; Apnoeic ventilation; Operative hysteroscopy; THRIVE

Outcome Measures

Primary Outcomes (1)

• Rate of success of ventilation with THRIVE.

  Comparison of the rate of success in airways management with the THRIVE system versus positive pressure ventilation by laryngeal mask. The failure of the method will be defined as a CO2 value measured by transcutaneous monitor (Radiometer) \> 65 mmHg AND/OR a peripheral O2 saturation measured by pulse oximeter \< 94%.

  Throughout the surgical procedure

Secondary Outcomes (4)

• Airway related complications.

  At the end of the surgery.

• Postoperative complications - 1

  At the end of the surgery.

• Postoperative complications - 2

  At the end of the surgery.

• Postoperative complications - 3

  At the end of the surgery.

Study Arms (2)

THRIVE

EXPERIMENTAL

Ventilatory management during surgery provided by transnasal humidified rapid-insufflation ventilatory exchange.

Device: Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE).

Control

ACTIVE COMPARATOR

Ventilatory management during surgery provided by mechanical ventilation through laringeal mask

Device: LMA

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.

THRIVE

LMA DEVICE

Mechanical ventilation performed by a laringeal mask

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing operative hysteroscopy
• ASA I-II.

You may not qualify if:

• BMI \> 30,
• pregnancy,
• cardiac arrhythmia,
• high risk of aspiration,
• neuromuscular disease,
• patient refusal.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Fondazione Policlinico A. Gemelli

Rome, 00167, Italy

Location

Related Publications (20)

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  PMID: 13630833 RESULT

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  PMID: 25388828 RESULT

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  PMID: 6808323 RESULT

• Hermez LA, Spence CJ, Payton MJ, Nouraei SAR, Patel A, Barnes TH. A physiological study to determine the mechanism of carbon dioxide clearance during apnoea when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE). Anaesthesia. 2019 Apr;74(4):441-449. doi: 10.1111/anae.14541. Epub 2019 Feb 15.

  PMID: 30767199 RESULT

• Brzek A, Dworrak T, Strauss M, Sanchis-Gomar F, Sabbah I, Dworrak B, Leischik R. The weight of pupils' schoolbags in early school age and its influence on body posture. BMC Musculoskelet Disord. 2017 Mar 21;18(1):117. doi: 10.1186/s12891-017-1462-z.

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  PMID: 20406507 RESULT

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  PMID: 25869405 RESULT

• Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.

  PMID: 26329355 RESULT

• Chikata Y, Onodera M, Oto J, Nishimura M. FIO2 in an Adult Model Simulating High-Flow Nasal Cannula Therapy. Respir Care. 2017 Feb;62(2):193-198. doi: 10.4187/respcare.04963. Epub 2016 Nov 22.

  PMID: 27879385 RESULT

• Moller W, Feng S, Domanski U, Franke KJ, Celik G, Bartenstein P, Becker S, Meyer G, Schmid O, Eickelberg O, Tatkov S, Nilius G. Nasal high flow reduces dead space. J Appl Physiol (1985). 2017 Jan 1;122(1):191-197. doi: 10.1152/japplphysiol.00584.2016. Epub 2016 Nov 17.

  PMID: 27856714 RESULT

• Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036.

  PMID: 28403407 RESULT

• Wong DT, Dallaire A, Singh KP, Madhusudan P, Jackson T, Singh M, Wong J, Chung F. High-Flow Nasal Oxygen Improves Safe Apnea Time in Morbidly Obese Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Oct;129(4):1130-1136. doi: 10.1213/ANE.0000000000003966.

  PMID: 31584919 RESULT

• Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.

  PMID: 32398433 RESULT

• Shih CC, Liang PC, Chuang YH, Huang YJ, Lin PJ, Wu CY. Effects of high-flow nasal oxygen during prolonged deep sedation on postprocedural atelectasis: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):1025-1031. doi: 10.1097/EJA.0000000000001324.

  PMID: 32890016 RESULT

• Itagaki T, Okuda N, Tsunano Y, Kohata H, Nakataki E, Onodera M, Imanaka H, Nishimura M. Effect of high-flow nasal cannula on thoraco-abdominal synchrony in adult critically ill patients. Respir Care. 2014 Jan;59(1):70-4. doi: 10.4187/respcare.02480. Epub 2013 Jun 4.

  PMID: 23737548 RESULT

• Kagan I, Hellerman-Itzhaki M, Neuman I, Glass YD, Singer P. Reflux events detected by multichannel bioimpedance smart feeding tube during high flow nasal cannula oxygen therapy and enteral feeding: First case report. J Crit Care. 2020 Dec;60:226-229. doi: 10.1016/j.jcrc.2020.08.005. Epub 2020 Aug 22.

  PMID: 32882605 RESULT

• Coudroy R, Frat JP, Ehrmann S, Pene F, Terzi N, Decavele M, Prat G, Garret C, Contou D, Bourenne J, Gacouin A, Girault C, Dellamonica J, Malacrino D, Labro G, Quenot JP, Herbland A, Jochmans S, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thevenin D, Grasselli G, Assefi M, Guerin C, Bougon D, Lherm T, Kouatchet A, Ragot S, Thille AW; REVA Network. High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol. BMJ Open. 2019 Aug 10;9(8):e029798. doi: 10.1136/bmjopen-2019-029798.

  PMID: 31401603 RESULT

• Mauri T, Galazzi A, Binda F, Masciopinto L, Corcione N, Carlesso E, Lazzeri M, Spinelli E, Tubiolo D, Volta CA, Adamini I, Pesenti A, Grasselli G. Impact of flow and temperature on patient comfort during respiratory support by high-flow nasal cannula. Crit Care. 2018 May 9;22(1):120. doi: 10.1186/s13054-018-2039-4.

  PMID: 29743098 RESULT

• Frassanito L, Grieco DL, Vassalli F, Piersanti A, Scorzoni M, Ciano F, Zanfini BA, Catarci S, Catena U, Scambia G, Antonelli M, Draisci G. High-Flow Nasal Oxygen versus Mechanical Ventilation Through a Laryngeal Mask During General Anesthesia Without Muscle Paralysis: A Randomized Clinical Trial. Anesth Analg. 2025 Nov 1;141(5):1116-1125. doi: 10.1213/ANE.0000000000007620. Epub 2025 Jul 21.

  PMID: 40690380 DERIVED

MeSH Terms

Conditions

Hypertrophy; Butyrylcholinesterase deficiency

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 22, 2022
• Study Start: June 17, 2022
• Primary Completion: October 1, 2022
• Study Completion: May 1, 2023
• Last Updated: September 5, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)