University Hospital Inselspital
Bern, 3008, Switzerland
NCT Number: NCT03478774
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bern, 3008, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HFNCT will be provided using OptiFlow by Fisher&Paykel.
Other names: high flow
Medium flow will be applied with a humidifier (Hudson RCI) and a standard nasal cannula.
Other names: medium flow
Low flow will be applied with a humidifier (Hudson RCI) and a standard nasal cannula.
Other names: low flow
Continuous
Continuous
0.25l/min of oxygen via an endotracheal tube
Other names: minimal flow
Time frame: 15 or 30 minutes (maximum apnea time)
pCO2 will be measured transcutaneously throughout the apnea period
Time frame: During apnea period (until end-point is met or max. 15 or 30 minutes)
Lowest SpO2 in %
Time frame: During apnea period (until end-point is met or max. 15 or 30 minutes)
Blood gas analyses as well as transcutaneous measurement
Time frame: During apnea period (until end-point is met or max. 15 or 30 minutes)
Cardiac output will be measured using pulse pressure measurement
Time frame: During apnea period (until end-point is met or max. 15 or 30 minutes)
Near infrared spectroscopy will be measured continuously
Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)
To quantify atelectasis during apnoeic oxygenation
Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)
Measurement of change due to hypercarbia
Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)
3 pole ECG
Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)
Using Narcotrend-EEG
Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)
Using NIRS
Time frame: 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.
pH
Time frame: 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.
pCO2 in mmhg
Time frame: 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.
pO2 in mmhg
Time frame: 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.
SaO2 in %
Time frame: 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.
Potassium in mmol
Time frame: 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.
Bicarbonate in mmol
Time frame: Morning of first postoperative day
Visual analogue scale (VAS) : pain, nausea, vomiting, feeling worried or anxious, feeling sad or depressed, injuries, discomfort, any complications
Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)
Pulse oximetry SpO2 in %
Insel Gruppe AG, University Hospital Bern
Other
Acronym: PHARAO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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