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OxygenNCT05291117

THRIVE Ventilation for Operative Hysteroscopy Under General Anesthesia

An observational study of Oxygen and General Anesthesia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min in order to maintain viable gas exchange during an extended period of cessation of spontaneous ventilation. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Oxygen, General Anesthesia, Hysteroscopy
How many people
30 participants
Where
1 siteItaly
Study dates
1 Feb 2022to 1 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women scheduled for elective operative hysteroscopies will be included.

Who may be able to join

  • ASA I-II.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Policlinico Agostino Gemelli

    Rome, 00168

Other trials in Italy

About this study

Official title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Apnoeic Ventilation During Operative Hysteroscopic Procedures Under General Anesthesia: an Observational Study.

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min in order to maintain viable gas exchange during an extended period of cessation of spontaneous ventilation.

This technique has been successfully applied in several clinical settings (induction of general anesthesia, laryngoscopy in predicted difficult airway management, and as unique airway management technique for procedural sedation or general anesthesia for brief surgical procedures).

Read more

Operative hysteroscopy is a brief surgical procedure usually performed under general anesthesia with intravenous agents (propofol plus fentanyl) and positive pressure ventilation through facial or laryngeal mask.

The aim of this study is to investigate the effects of THRIVE apnoeic ventilation during hysteroscopy under general anesthesia. Our primary outcome is to describe the trend of SpO2 and tcCO2 during the procedures.

Secondary outcomes include description of arrhythmias requiring medical treatment, hemodynamic instability, unmanageable copious secretions, airway obstruction or inability to maintain airway patency, witnessed aspiration, airway related complications, number of airway manipulations, adverse events, assessment of postoperative dyspnoea and comfort, patient satisfaction.

Women (> 18 years old and < 70 years old), ASA physical status I and II presenting for elective operative hysteroscopies will be included.

A number of 30 patients was planned to target the primary outcome.

Read the detailed description

Background Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE), term coined by Patel and Nouraei, refers to a technique that allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min using the Optiflow THRIVE-TM system (Fisher and Paykel Healthcare Ltd, Auckland, New Zealand), in order to maintain viable gas exchange during an extended period of cessation of muscular activity.

Apnoeic oxygenation is a physiological phenomenon in which oxygen flow into the lungs is driven by a negative pressure gradient generated by the difference between the alveolar rates of oxygen absorption and carbon dioxide excretion.

Potentially rapid and dangerous rise in carbon dioxide concentration is prevented by the underlying mechanisms occurring during high-flow nasal oxygenation under apnoeic conditions.

As proposed by Slutsky and more recently by Hermez, cardiogenic oscillations (changes in airway gas flow and pressure synchronous with the cardiac cycle) and their interactions with supraglottic turbulence generated by high-flow nasal oxygenation might be the underlying mechanisms of THRIVE and of the enhanced clearance of carbon dioxide.

Many clinically relevant benefits have been associated with nasal high flow. It provides a constant FiO2 by delivering the gas at flow rates that exceed the patient's peak inspiratory flow rate. It is effective in providing a flow-dependent effect of continuous positive airway pressure of about 1 cmH20 for every 10 L/min increase in gas flow within a range of 30-50 L/min, up to 11.9 cm H20 at a maximum flow of 100 L/min. Moreover, it reduces respiratory rate, it clears in a dose-dependent manner dead space of the upper airways and possibly even below the soft palate, leading to a reduction in rebreathing of expired air, with the potential to increase the alveolar volume and to improve alveolar ventilation and gas exchange. It is likely that, especially in patients with mild to moderate respiratory failure, enhanced comfort from heated humidification and flushing of dead space, lessen the work of breathing, thus improving thoraco-abdominal synchrony. By contrast, in spontaneously breathing patients, as a consequence of the large amount of air inflated into the stomach, higher number of reflux events could be detected increasing the risks of aspiration.

This technique has been successfully applied in several clinical settings to extend the apnoeic window after the induction of general anesthesia and during laryngoscopy in predicted difficult airway management. As long as airway patency was present, it succeeded in extending the apnoeic window up to 65 minutes. PaO2 and peripheral oxygen saturation remained stable and the rate of rise of CO2 during apnoea was reduced from earlier findings of 0.5 kPa/min with conventional low-flow systems to 0.15 kPa/min.

THRIVE has also been used as unique airway management technique for procedural sedation or when general anesthesia was performed for brief surgical procedures: it was able to keep patients with mild systemic disease well oxygenated, maintaining PaO2 stable with decreased rates of rise of CO2 during apnoea, as compared to conventional low-flow systems for oxygen therapy, such as the Venturi mask.

Operative hysteroscopy is a brief surgical procedure (< 30 minutes), usually performed in a day-surgery regimen. Typical anesthesiologic management in this setting includes general anesthesia with intravenous agents (propofol plus fentanyl) and positive pressure ventilation through laryngeal mask (I-gel). The application of THRIVE in this setting has potential advantages either for the patient, including minimal airway manipulation and greater comfort, either for the anesthesia provider, facilitating procedural technique and airway management.

Aim of the study The aim of this study is to investigate the effects of THRIVE apnoeic ventilation during operative hysteroscopy under general anesthesia.

Monitoring Standard perioperative monitoring will include non-invasive blood pressure (NIBP) with an upper arm cuff, 3-lead ECG, peripheral oxygen saturation (SpO2) and bispectral index (BIS). NIBP will be measured every 5 minutes before induction of anesthesia and throughout the procedure. Transcutaneous carbon dioxide (tcCO2) will be continuously monitored by Radiometer TCM5 monitor.

Study protocol Upon arrival on the operating theatre, each patient will be placed in supine position in lithotomic position; a peripheral venous cannula will be inserted on the hand or forearm and 500 ml Ringer-Lactate solution infusion will be started. Omeprazole 40 mg and dexametasone 4 mg will be given preoperatively. 3 minutes of pre-oxygenation will be performed with 100% oxygen 30 L/min delivered via dedicated Optiflow THRIVE-TM nasal cannulae. General anesthesia will then be induced with target-controlled infusion (TCI) of propofol (7 mcg/kg) through Orchestra Infusion system (Fresenius Kabi) plus fentanyl (1,5 mcg/kg). The range of maintenance of propofol concentration will be 4-6 mcg/ml, titrated to maintain a level of anesthesia monitored by BIS between 40 and 50. With the onset of general anesthesia oxygen flow will be increased to 70 L/min and maintained throughout the procedure. Head repositioning, jaw thrust, oropharyngeal cannula placement could be used to improve airway patency during the procedure. In case of episodes of oxygen desaturation, defined as SpO2<94%, or rise of tcCO2 over 45 mmHg, positive pressure ventilation by facial mask or laryngeal mask will be applied by the practitioner based on clinical judgement.

At the end of the procedure, propofol will be stopped. Paracetamol 1g, ondansetron 4 mg and ketorolac 30 mg will be administered as routine clinical practice.

The awake patient will be moved to the PACU for three hours of post-operative monitoring as required by internal practice for day-surgery procedures. Standard monitoring will include NIBP measured every 15 minutes, 3-lead ECG, and peripheral oxygen saturation (SpO2).

One hour after the end of the procedure and before discharge from the PACU the patient will be asked to rate its perceived degree of dyspnoea with the Borg dyspnoea score and its degree of comfort by Visual Numerical Scale (VAS).

In case of episodes of oxygen desaturation, defined as SpO2<94%, supplemental oxygen will be initially provided to the patient by low-flow Venturi mask with FiO2 40%.

Discharge from the PACU will require an Aldrete score of 9-10.

Sample size calculation For this pilot study no sample size calculation was performed.

Keywords
Transnasal humified high flow oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of tCO2 during THRIVE ventilation.

    CO2 values (reported as mmHg) measured by Radiometer monitor.

    Measured: pre-anesthesia; up to 1 hour.

  2. change of SpO2 during THRIVE ventilation.

    SpO2 values (reported as "%") measured by oxymeter.

    Measured: pre-anesthesia; up to 1 hour.

Secondary outcomes (4)
  1. Airway related complications.

    Incidence of patients requiring airway manipulations (nasal cannula, manual ventilation, laryngeal mask ventilation, tracheal intubation) by the anesthesiologist, reported as "% of total number of patients".

    Measured: 2 hours after the end of anesthesia.

  2. Postoperative complications - 1

    Incidence of patients suffering from cough, sore throat, dysphagia, dysphonia, laryngospasm, oxygen desaturation (defined as SpO2<94%), reported as "% of total number of patients"

    Measured: 2 hours after the end of anesthesia.

  3. Postoperative complications - 2

    Incidence of dyspnoea (measured with Borg dyspnoea score: 0= no dyspnoea, 10= maximal dyspnoea).

    Measured: 2 hours after the end of anesthesia.

  4. Postoperative complications - 3

    Incidence of discomfort (measured with Visual Analogue Scale: 0= no discomfort, 10= maximal discomfort).

    Measured: 2 hours after the end of anesthesia.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Apr 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05291117
Sponsor's protocol ID
4631
Status last verified
Apr 2022
First submitted
19 Jan 2022
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • BARTLETT RG Jr, BRUBACH HF, SPECHT H. Demonstration of aventilatory mass flow during ventilation and apnea in man. J Appl Physiol. 1959 Jan;14(1):97-101. doi: 10.1152/jappl.1959.14.1.97. No abstract available.

    PubMed 13630833
  • Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.

    PubMed 25388828
  • O'Cain CF, Dowling NB, Slutsky AS, Hensley MJ, Strohl KP, McFadden ER Jr, Ingram RH Jr. Airway effects of respiratory heat loss in normal subjects. J Appl Physiol Respir Environ Exerc Physiol. 1980 Nov;49(5):875-80. doi: 10.1152/jappl.1980.49.5.875.

    PubMed 7429910
  • Slutsky AS, Brown R. Cardiogenic oscillations: a potential mechanism enhancing oxygenation during apneic respiration. Med Hypotheses. 1982 Apr;8(4):393-400. doi: 10.1016/0306-9877(82)90032-9.

    PubMed 6808323
  • 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.

    PubMed 30767199
  • Hernandez G, Roca O, Colinas L. High-flow nasal cannula support therapy: new insights and improving performance. Crit Care. 2017 Mar 21;21(1):62. doi: 10.1186/s13054-017-1640-2.

    PubMed 28320436
  • Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.

    PubMed 20406507
  • Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14.

    PubMed 25869405
  • 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.

    PubMed 26329355
  • 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.

    PubMed 27879385
  • 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.

    PubMed 27856714
  • 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.

    PubMed 28403407
  • 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.

    PubMed 31584919
  • 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.

    PubMed 32398433
  • 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.

    PubMed 32890016

Questions about this trial

What is this clinical trial studying?

An observational study of Oxygen and General Anesthesia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of tCO2 during THRIVE ventilation. (time frame: pre-anesthesia; up to 1 hour.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05291117, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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