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

NCT03478774 | Completed

• 1 other identifier: 2018-00293
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apnoeic Oxygenation

Outcome Measures

Primary Outcomes (1)

• pCO2 increase in kPa/min

  pCO2 will be measured transcutaneously throughout the apnea period

  15 or 30 minutes (maximum apnea time)

Secondary Outcomes (17)

• Lowest Saturation

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

• Change in PaO2 in kPa

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

• Change in cardiac output in L/min

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

• Change in cerebral perfusion in %

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

• Changes in end-expiratory lung impedance

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

Study Arms (5)

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.

Drug: Oxygen 70l/min; Procedure: Videolaryngoscopy

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.

Drug: Oxygen 70l/min; Procedure: Jaw thrust

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.

Drug: Oxygen 10 l/min; Procedure: Jaw thrust

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.

Drug: Oxygen 2l/min; Procedure: Jaw thrust

minimal flow

EXPERIMENTAL

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.

Drug: oxygen 0.25l/min

Interventions

Oxygen 70l/min DRUG

HFNCT will be provided using OptiFlow by Fisher\&Paykel.

Also known as: high flow

Control; High flow

Oxygen 10 l/min DRUG

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

Also known as: medium flow

medium flow

Oxygen 2l/min DRUG

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

Also known as: low flow

low flow

Jaw thrust PROCEDURE

Continuous

High flow; low flow; medium flow

Videolaryngoscopy PROCEDURE

Continuous

Control

oxygen 0.25l/min DRUG

0.25l/min of oxygen via an endotracheal tube

Also known as: minimal flow

minimal flow

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Inselspital

Bern, 3008, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 25388828 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.

  PMID: 28403407 BACKGROUND

• 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.

  PMID: 37262066 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.

  PMID: 36170281 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.

  PMID: 31300494 DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Lorenz Theiler, PD MD

  University hospital of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single centre, prospective, randomized-controlled trial

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 27, 2018
• Study Start: March 25, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

CH (1)