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This study compares under controlled conditions if different flow rates affect apnoea time after induction of anaesthesia and how CO2 clearance is influenced. Furthermore, this study enables to quantify the effects of increased pCO2 on vital parameters (e.g. blood pressure, cardiac output, cerebral perfusion, etc.) The investigators will enroll patients undergoing elective surgery at the University Hospital of Bern, Switzerland.
Once anesthesia has been induced, apnoea will set it. During this period, the investigators will compare different methods of apnoeic oxygenation for a maximum of 15 or 30 minutes.
Before discharge, an interview will be conducted, assessing complications and patient satisfaction.
Eligible, consenting adults will be prepared for general anaesthesia in the usual way consisting of ECG, pulse-oximetry, NarcotrendTM, a venous cannula and an arterial line for continuous blood pressure monitoring. They will receive additional monitoring such as transcutaneous measurement of pCO2 and O2, NIRS, and thoracic electrical impedance tomography (EIT, PulmoVista® 500, Draeger, Luebeck, Germany).
Normal pre-oxygenation (until etO2 is > 90% or time > 3 minutes) will occur. Anaesthesia will be started (= "induction") using Propofol and Fentanyl, using NarcotrendTM to measure depth of anaesthesia. All patients will receive a standard dose of neuromuscular blockage to facilitate airway management and total intravenous anaesthesia will be installed. Using the train of four measurement (TOF) full neuromuscular blockage with Rocuronium will be confirmed every 30 seconds. If necessary, additional dosage of neuromuscular blockage will be administered.
After administration of Rocuronium, possibility of mask ventilation will be confirmed and the sealed envelope with the randomization will then be opened. As a study intervention, the assigned method (HFNCT 70 l/min with either jaw thrust or laryngoscopy, or 10 l/min or 2l/min with the standard nasal canula, or 0.25l/min delivery of oxgen via a tracheal tube) will be installed and mask ventilation discontinued starting the apnoea period. Nasopharyngoscopy (EF-N slim, Acutronic, Hirzel, Switzerland) will confirm upper airway patency. Blood gas analysis will be conducted: baseline awake, start of apnoea, first minute after apnoea start, and every 2 minutes thereafter with a maximum of 75ml 150 ml in total. Other measurements (ECG, pulse-oximetry, blood pressure, NIRS, thoracic EIT, NarcotrendTM, PtcO2, PtcCO2) will be measured continuously over the study period The study intervention will end when one of the following criteria (study end-points) is met: SpO2 <92%, PtcCO2 > 100 mmHg or time > 30 minutes.
When any of the end points is reached, patient-centred standard anaesthesia care will be continued, as planned for the case.
A post-operative interview will be conducted before discharge to evaluate injuries during airway management (bleeding, sore throat, hoarseness), pain, postoperative nausea and vomiting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | These patients will receive HFNCT with oxygen 70l/min after induction of general anesthesia. Throughout the entire measurement period of 15 or 30 minutes, continuous videolaryngoscopy will be performed. |
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| High flow | Experimental | These patients will receive HFNCT with oxygen 70l/min after induction of general anesthesia. Throughout the entire measurement period of 15 or 30 minutes, jaw thrust will be performed. |
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| medium flow | Experimental | These patients will receive oxygen 10l/min after induction of general anesthesia. Throughout the entire measurement period of 15 or 30 minutes, jaw thrust will be performed. |
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| low flow | Experimental | These patients will receive oxygen 2l/min after induction of general anesthesia. Throughout the entire measurement period of 15 or 30 minutes, jaw thrust will be performed. |
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| minimal flow | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen 70l/min | Drug | HFNCT will be provided using OptiFlow by Fisher&Paykel. |
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| Measure | Description | Time Frame |
|---|---|---|
| pCO2 increase in kPa/min | pCO2 will be measured transcutaneously throughout the apnea period | 15 or 30 minutes (maximum apnea time) |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest Saturation | Lowest SpO2 in % | During apnea period (until end-point is met or max. 15 or 30 minutes) |
| Change in PaO2 in kPa | Blood gas analyses as well as transcutaneous measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenz Theiler, PD MD | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Inselspital | Bern | 3008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25388828 | Background | 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. | |
| 28403407 | Background | 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. |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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single centre, prospective, randomized-controlled trial
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Patients will be blinded as they receive general anesthesia. Care providers cannot be blinded, due to obvious differences in set-up of the different interventions.
These patients will receive a standard tracheal tubes after induction of general anesthesia, with 100% Oxygen and Minimum-flow 0.25l/min. The measurement period is 15 or 30 minutes.
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| Oxygen 10 l/min | Drug | Medium flow will be applied with a humidifier (Hudson RCI) and a standard nasal cannula. |
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| Oxygen 2l/min | Drug | Low flow will be applied with a humidifier (Hudson RCI) and a standard nasal cannula. |
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| Jaw thrust | Procedure | Continuous |
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| Videolaryngoscopy | Procedure | Continuous |
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| oxygen 0.25l/min | Drug | 0.25l/min of oxygen via an endotracheal tube |
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| During apnea period (until end-point is met or max. 15 or 30 minutes) |
| Change in cardiac output in L/min | Cardiac output will be measured using pulse pressure measurement | During apnea period (until end-point is met or max. 15 or 30 minutes) |
| Change in cerebral perfusion in % | Near infrared spectroscopy will be measured continuously | During apnea period (until end-point is met or max. 15 or 30 minutes) |
| Changes in end-expiratory lung impedance | To quantify atelectasis during apnoeic oxygenation | During apnoea time (until end-point is met or max. 15 or 30 minutes) |
| Change in invasive blood pressure | Measurement of change due to hypercarbia | During apnoea time (until end-point is met or max. 15 or 30 minutes) |
| Standard monitoring | 3 pole ECG | During apnoea time (until end-point is met or max. 15 or 30 minutes) |
| Depth of anaesthesia | Using Narcotrend-EEG | During apnoea time (until end-point is met or max. 15 or 30 minutes) |
| Bilateral brain oxygenation | Using NIRS | During apnoea time (until end-point is met or max. 15 or 30 minutes) |
| Arterial blood gas analyses | pH | At 0, 1, 3, 5, 7, 9, 11, 13 and 15 minutes of apnoea or 0,1,3,5,7,9,13,15,17,19,21,23,25,27,29 and 30 min of apnoea. |
| Arterial blood gas analyses | pCO2 in mmhg | At 0, 1, 3, 5, 7, 9, 11, 13 and 15 minutes of apnoea or 0,1,3,5,7,9,13,15,17,19,21,23,25,27,29 and 30 min of apnoea. |
| Arterial blood gas analyses | pO2 in mmhg | At 0, 1, 3, 5, 7, 9, 11, 13 and 15 minutes of apnoea or 0,1,3,5,7,9,13,15,17,19,21,23,25,27,29 and 30 min of apnoea. |
| Arterial blood gas analyses | SaO2 in % | At 0, 1, 3, 5, 7, 9, 11, 13 and 15 minutes of apnoea or 0,1,3,5,7,9,13,15,17,19,21,23,25,27,29 and 30 min of apnoea. |
| Arterial blood gas analyses | Potassium in mmol | At 0, 1, 3, 5, 7, 9, 11, 13 and 15 minutes of apnoea or 0,1,3,5,7,9,13,15,17,19,21,23,25,27,29 and 30 min of apnoea. |
| Arterial blood gas analyses | Bicarbonate in mmol | At 0, 1, 3, 5, 7, 9, 11, 13 and 15 minutes of apnoea or 0,1,3,5,7,9,13,15,17,19,21,23,25,27,29 and 30 min of apnoea. |
| Postoperative questionnaire | Visual analogue scale (VAS) : pain, nausea, vomiting, feeling worried or anxious, feeling sad or depressed, injuries, discomfort, any complications | Morning of first postoperative day |
| Standard monitoring | Pulse oximetry SpO2 in % | During apnoea time (until end-point is met or max. 15 or 30 minutes) |
| 37262066 | Derived | Schweizer T, Hartwich V, Riva T, Kaiser H, Theiler L, Greif R, Nabecker S. Limitations of transcutaneous carbon dioxide monitoring in apneic oxygenation. PLoS One. 2023 Jun 1;18(6):e0286038. doi: 10.1371/journal.pone.0286038. eCollection 2023. |
| 36170281 | Derived | Riedel T, Burgi F, Greif R, Kaiser H, Riva T, Theiler L, Nabecker S. Changes in lung volume estimated by electrical impedance tomography during apnea and high-flow nasal oxygenation: A single-center randomized controlled trial. PLoS One. 2022 Sep 28;17(9):e0273120. doi: 10.1371/journal.pone.0273120. eCollection 2022. |
| 31300494 | Derived | Theiler L, Schneeberg F, Riedel T, Kaiser H, Riva T, Greif R. Apnoeic oxygenation with nasal cannula oxygen at different flow rates in anaesthetised patients: a study protocol for a non-inferiority randomised controlled trial. BMJ Open. 2019 Jul 11;9(7):e025442. doi: 10.1136/bmjopen-2018-025442. |