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Completed

NCT Number: NCT03478774

Physiology Regarding Apnoeic Oxygenation During Nasal Cannula Therapy at Different Flow Rates

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Inselspital

Bern, 3008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years
  • Written informed consent
  • Undergoing elective surgery
  • Requiring general anesthesia

Exclusion criteria

  • Any Indication for fibre optic intubation
  • Expected impossible mask ventilation
  • Known coronary heart disease
  • Known heart failure, NYHA classification ≥ 2
  • Therapy including β-receptor antagonists
  • Arrhythmias in need of anti-arrhythmic therapy (e.g. implanted cardio defibrillator)
  • Peripheral occlusive arterial disease, Fontaine ≥ 2b
  • Known stenosis of the (common or internal) carotid or vertebral arteries
  • BMI > 35kg/m2 and BMI < 16kg/m2
  • Hyperkalaemia (K > 5.5 mmol/l)
  • Known COPD Gold classification ≥ 2
  • Known pulmonary arterial hypertension, systolic > 35mmHg
  • Known obstructive sleep apnoea syndrome in need of therapy
  • High risk of aspiration (requiring rapid sequence induction intubation)
  • Increased intracranial pressure
  • Intracranial surgery
  • Limited knowledge of German language
  • Absent power of judgement
  • Anaemia, Hb < 100 g/l
  • Pregnancy (pregnancy test in all female patients)
  • Neuromuscular disorder
  • Known or suspected cervical spine instability
  • Nasal obstruction, impossibility of nasal ventilation (both sides patent)
  • Allergies or contra-indications to one or more of the used anaesthesia agents

Treatment and study plan

Oxygen 70l/min

Drug

HFNCT will be provided using OptiFlow by Fisher&Paykel.

Other names: high flow

Oxygen 10 l/min

Drug

Medium flow will be applied with a humidifier (Hudson RCI) and a standard nasal cannula.

Other names: medium flow

Oxygen 2l/min

Drug

Low flow will be applied with a humidifier (Hudson RCI) and a standard nasal cannula.

Other names: low flow

jaw thrust

Procedure

Continuous

Videolaryngoscopy

Procedure

Continuous

oxygen 0.25l/min

Drug

0.25l/min of oxygen via an endotracheal tube

Other names: minimal flow

Primary outcomes

  1. pCO2 increase in kPa/min

    Time frame: 15 or 30 minutes (maximum apnea time)

    pCO2 will be measured transcutaneously throughout the apnea period

Secondary outcomes

  1. Lowest Saturation

    Time frame: During apnea period (until end-point is met or max. 15 or 30 minutes)

    Lowest SpO2 in %

  2. Change in PaO2 in kPa

    Time frame: During apnea period (until end-point is met or max. 15 or 30 minutes)

    Blood gas analyses as well as transcutaneous measurement

  3. Change in cardiac output in L/min

    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

  4. Change in cerebral perfusion in %

    Time frame: During apnea period (until end-point is met or max. 15 or 30 minutes)

    Near infrared spectroscopy will be measured continuously

  5. Changes in end-expiratory lung impedance

    Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)

    To quantify atelectasis during apnoeic oxygenation

  6. Change in invasive blood pressure

    Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)

    Measurement of change due to hypercarbia

  7. Standard monitoring

    Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)

    3 pole ECG

  8. Depth of anaesthesia

    Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)

    Using Narcotrend-EEG

  9. Bilateral brain oxygenation

    Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)

    Using NIRS

  10. Arterial blood gas analyses

    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

  11. Arterial blood gas analyses

    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

  12. Arterial blood gas analyses

    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

  13. Arterial blood gas analyses

    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 %

  14. Arterial blood gas analyses

    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

  15. Arterial blood gas analyses

    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

  16. Postoperative questionnaire

    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

  17. Standard monitoring

    Time frame: During apnoea time (until end-point is met or max. 15 or 30 minutes)

    Pulse oximetry SpO2 in %

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: PHARAO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2018
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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