Laryngeal DiseaseCAPOXNCT06316063
Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery
A study testing Apnoeic oxygenation with high-flow nasal oxygen and Mechanical ventilation in people with Laryngeal Disease, run by Region Stockholm at 1 site in Sweden.
Trial summary
During apnoeic oxygenation there is a continuous raise in carbon dioxide with subsequent respiratory acidosis. The hypercapnia and respiratory acidosis have several dose-related effects on both the systemic and the pulmonary circulation and the heart that ultimately, if unrecognised, can result in cardiovascular… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Laryngeal Disease
- What is being tested?
- Apnoeic oxygenation with high-flow nasal oxygen and Mechanical ventilation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 25 Mar 2024to 31 Jan 2025
- Phase
- Interventional
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, ≥18 years old
- ASA 1-2
- BMI < 30
- Planned for elective laryngeal surgery
Who cannot join
- NYHA-class >1
- Pregnancy
- Severe gastric reflux
- Neuromuscular disease
- Any pulmonary disease
- Smokers or former smoker, last finished 6 months before inclusion
- Not capable of understanding study information and signing a written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery - a Randomised Study
During apnoeic oxygenation there is a continuous raise in carbon dioxide with subsequent respiratory acidosis. The hypercapnia and respiratory acidosis have several dose-related effects on both the systemic and the pulmonary circulation and the heart that ultimately, if unrecognised, can result in cardiovascular collapse and fatal arrhythmias. In our knowledge, no studies have investigated the haemodynamic effects of apnoeic oxygenation with HFNO.
The general purpose of this project is to investigate haemodynamic alternations during apnoeic oxygenation with HFNO compared to mechanical ventilation in relatively healthy patients under general anaesthesia during laryngeal surgery.
Read the detailed description
This study aims to investigate and observe the circulatory effects in a patient undergoing apnoeic oxygenation with HFNO during shorter elective laryngeal surgery over time and compared to mechanical ventilation. 20 patients scheduled for elective laryngeal surgery, eligible for apnoeic oxygenation at the Karolinska University Hospital, will be recruited. If eligible, the patient will receive oral and written study information by one of the investigators well in advance of the planned surgery. After a signed consent, the subject will be enrolled and randomised to either apnoeic oxygenation with HFNO or mechanical ventilation.
Patient characteristics such as age, sex, weight, height, ASA classification, other comorbidities and airway-related parameters will be documented. A preoperative transthoracic echocardiographic examination and routine perioperative monitoring, will be performed together with a 12-lead ECG. Preoperatively, an arterial catheter will be inserted in the radial artery and an arterial blood gas, measuring PaCO2, PaO2, pH, HCO3 and blood samples of stress markers including catecholamines and other cardiac biomarkers will be collected. The FloTrac system will be connected to the arterial catheter and baseline values will be registered. A peripheral venous catheter is placed prior to anaesthesia and the patient is placed supine.
In the apnoeic oxygenation group the HFNO nasal prongs (Optiflow, Fisher \& Paykel Healthcare, Auckland, New Zealand) is placed in the nostrils and used for pre-oxygenation, 100 % O2, 40 L/min during 3 min. Thereafter, anaesthesia is induced by intravenous Propofol and Remifentanil administration. Rocuronium for full neuromuscular blockade is administered and a jaw thrust is used to keep an open airway. The start of apnoea is noted, defined as 1 minute after Rocuronium administration. The airway will be kept patent throughout the procedure using a suspension laryngoscope, placed by the ENT surgeon.
During apnoea the flow of oxygen is increased to 70 L/min, 100% O2. Apnoea will be discontinued if any of the criteria SpO2 < 90%, PaCO2 >11 kPa, pH <7.15 or arrhythmias with haemodynamic effects occur. In the mechanical ventilation group pre-oxygenation is performed by a tight-fitting facemask, 100 % O2, for three minutes. After anaesthesia induction using intravenous Propofol and Remifentanil and Rocuronium for full neuromuscular blockade, tracheal intubation is performed and mechanical ventilation is started. The start of apnoea is noted. The ventilator is set to PEEP 5 cmH2O, tidal volume (TV) 7 ml/kg ideal body weight, FiO2 0.4, and the respiratory frequency adjusted to reach a PaCO2 of 5,0 -5,3 kPa. Standard perioperative monitoring will be registered (peripheral oxygen saturation, heart rate and MAP). Arterial blood gases will be collected and ECG performed repeatedly. Data from the FloTrac system will be monitored throughout the procedure. Transthoracic echocardiography will be performed regularly. Blood samples to analyse stress markers including catecholamines and cardiac biomarkers will be collected at specific timepoints.
At the end of the procedure, any neuromuscular blockade is reversed by Sugammadex. The end of apnoea is defined as reoccurrence of spontaneous breathing or start of mask ventilation. In the mechanically ventilated group, subjects are extubated when awake and responsive.
After the procedure and when fully awake, the patient is transferred to the post-operative unit. The FloTrac monitoring will be continued during the postoperative period and the TTE, ECG evaluation, arterial blood gases, stress markers including catecholamines and cardiac biomarkers will be repeated during the post-operative period. Routine postoperative monitoring will be performed for a minimum of 60 minutes.
- Conditions
- Laryngeal Disease
- Being tested
- Apnoeic oxygenation with high-flow nasal oxygen, Mechanical ventilation
- Keywords
- Apnoeic oxygenation, Pulmonary hypertension, High-flow nasal oxygen, Right ventricular function
- Medical subject headings
- Laryngeal Diseases, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apnoeic oxygenation with high-flow nasal oxygenDevice
The subjects in the intervention group will be oxygenated with HFNO during the surgical procedure.
Mechanical ventilationOther
Study subjects in the comparator group will be tracheally intubated and mechanically ventilated
| Study group | Role | What they receive |
|---|---|---|
| Apnoeic oxygenation with High-flow nasal oxygen | Experimental | In the apnoeic oxygenation group the HFNO is used for pre-oxygenation,100 % O2, 40 L/min during 3 min. Thereafter, anaesthesia is induced by intravenous Propofol and Remifentanil. Rocuronium for full neuromuscular blockade is administered and a jaw thrust is used to keep an open airway. The airway will be kept patent throughout the procedure using a suspension laryngoscope, placed by the ENT surgeon. During apnoea oxygen will be increased to 70 L/min, 100% O2. Apnoea will be discontinued if any of the criteria SpO2 < 90%, PaCO2 >11 kPa, pH <7.15 or arrhythmias with haemodynamic effects occur. Receives: Device: Apnoeic oxygenation with high-flow nasal oxygen |
| Mechanical ventilation | Active comparator | In the mechanical ventilation group pre-oxygenation is performed by a tight-fitting facemask, 100 % O2, for three minutes. After anaesthesia induction and full neuromuscular blockade, tracheal intubation is performed and mechanical ventilation is started. Receives: Other: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant haemodynamic effects during apnoeic oxygenation with HFNO
Significant haemodynamic effects such as significant increase in mPAP and/or new echocardiographic signs of right ventricular strain or failure compared to baseline, during and up to 2 hours after apnoeic oxygenation with HFNO or mechanical ventilation.
Measured: 3 hours
Secondary outcomes (4)
Alterations in FloTrac derived central haemodynamic parameters
Alterations in FloTrac derived central haemodynamic parameters such as MAP, SV, SVRI and CI, during and up to 2 hours after apnoeic oxygenation with HFNO or mechanical ventilation.
Measured: 3 hours
Alterations in Electrocardiogram
Alterations in electrocardiogram during and up to 2 hours after apnoeic oxygenation with HFNO or mechanical ventilation.
Measured: 3 hours
Alterations in arterial carbon dioxide, oxygen and pH
Alterations in arterial carbon dioxide, oxygen and pH during and up to 2 hours after apnoeic oxygenation with HFNO or mechanical ventilation.
Measured: 3 hours
Alterations in blood catecholamines and cardiac biomarkers
Alterations in blood catecholamines and cardiac biomarkers during and up to 2 hours after apnoeic oxygenation with HFNO or mechanical ventilation.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start25 Mar 2024
- Primary completion26 Nov 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DiseaseStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Malin Jonsson Fagerlund, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316063
- Sponsor's protocol ID
- 2023
- Acronym
- CAPOX
- Status last verified
- Nov 2024
- First submitted
- 12 Mar 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery - a Randomised Study
- ClinicalTrials.gov ID
- NCT06316063
- Acronym / sponsor ID
- CAPOX / 2023
- Conditions
- Laryngeal Disease
- Keywords
- Apnoeic oxygenation, Pulmonary hypertension, High-flow nasal oxygen, Right ventricular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During apnoeic oxygenation there is a continuous raise in carbon dioxide with subsequent respiratory acidosis. The hypercapnia and respiratory acidosis have several dose-related effects on both the systemic and the pulmonary circulation and the heart that ultimately, if unrecognised, can result in cardiovascular collapse and fatal arrhythmias. In our knowledge, no studies have investigated the haemodynamic effects of apnoeic oxygenation with HFNO.
The general purpose of this project is to investigate haemodynamic alternations during apnoeic oxygenation with HFNO compared to mechanical ventilation in relatively healthy patients under general anaesthesia during laryngeal surgery.
Detailed description
This study aims to investigate and observe the circulatory effects in a patient undergoing apnoeic oxygenation with HFNO during shorter elective laryngeal surgery over time and compared to mechanical ventilation. 20 patients scheduled for elective laryngeal surgery, eligible for apnoeic oxygenation at the Karolinska University Hospital, will be recruited. If eligible, the patient will receive oral and written study information by one of the investigators well in advance of the planned surgery. After a signed consent, the subject will be enrolled and randomised to either apnoeic oxygenation with HFNO or mechanical ventilation.
Patient characteristics such as age, sex, weight, height, ASA classification, other comorbidities and airway-related parameters will be documented. A preoperative transthoracic echocardiographic examination and routine perioperative monitoring, will be performed together with a 12-lead ECG. Preoperatively, an arterial catheter will be inserted in the radial artery and an arterial blood gas, measuring PaCO2, PaO2, pH, HCO3 and blood samples of stress markers including catecholamines and other cardiac biomarkers will be collected. The FloTrac system will be connected to the arterial catheter and baseline values will be registered. A peripheral venous catheter is placed prior to anaesthesia and the patient is placed supine.
In the apnoeic oxygenation group the HFNO nasal prongs (Optiflow, Fisher \& Paykel Healthcare, Auckland, New Zealand) is placed in the nostrils and used for pre-oxygenation, 100 % O2, 40 L/min during 3 min. Thereafter, anaesthesia is induced by intravenous Propofol and Remifentanil administration. Rocuronium for full neuromuscular blockade is administered and a jaw thrust is used to keep an open airway. The start of apnoea is noted, defined as 1 minute after Rocuronium administration. The airway will be kept patent throughout the procedure using a suspension laryngoscope, placed by the ENT surgeon.
During apnoea the flow of oxygen is increased to 70 L/min, 100% O2. Apnoea will be discontinued if any of the criteria SpO2 < 90%, PaCO2 >11 kPa, pH <7.15 or arrhythmias with haemodynamic effects occur. In the mechanical ventilation group pre-oxygenation is performed by a tight-fitting facemask, 100 % O2, for three minutes. After anaesthesia induction using intravenous Propofol and Remifentanil and Rocuronium for full neuromuscular blockade, tracheal intubation is performed and mechanical ventilation is started. The start of apnoea is noted. The ventilator is set to PEEP 5 cmH2O, tidal volume (TV) 7 ml/kg ideal body weight, FiO2 0.4, and the respiratory frequency adjusted to reach a PaCO2 of 5,0 -5,3 kPa. Standard perioperative monitoring will be registered (peripheral oxygen saturation, heart rate and MAP). Arterial blood gases will be collected and ECG performed repeatedly. Data from the FloTrac system will be monitored throughout the procedure. Transthoracic echocardiography will be performed regularly. Blood samples to analyse stress markers including catecholamines and cardiac biomarkers will be collected at specific timepoints.
At the end of the procedure, any neuromuscular blockade is reversed by Sugammadex. The end of apnoea is defined as reoccurrence of spontaneous breathing or start of mask ventilation. In the mechanically ventilated group, subjects are extubated when awake and responsive.
After the procedure and when fully awake, the patient is transferred to the post-operative unit. The FloTrac monitoring will be continued during the postoperative period and the TTE, ECG evaluation, arterial blood gases, stress markers including catecholamines and cardiac biomarkers will be repeated during the post-operative period. Routine postoperative monitoring will be performed for a minimum of 60 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apnoeic oxygenation with High-flow nasal oxygen | Experimental | Device: Apnoeic oxygenation with high-flow nasal oxygenIn the apnoeic oxygenation group the HFNO is used for pre-oxygenation,100 % O2, 40 L/min during 3 min. Thereafter, anaesthesia is induced by intravenous Propofol and Remifentanil. Rocuronium for full neuromuscular blockade is administered and a jaw thrust is used to keep an open airway. The airway will be kept patent throughout the procedure using a suspension laryngoscope, placed by the ENT surgeon. During apnoea oxygen will be increased to 70 L/min, 100% O2. Apnoea will be discontinued if any of the criteria SpO2 < 90%, PaCO2 >11 kPa, pH <7.15 or arrhythmias with haemodynamic effects occur. |
| Mechanical ventilation | Active comparator | Other: Mechanical ventilationIn the mechanical ventilation group pre-oxygenation is performed by a tight-fitting facemask, 100 % O2, for three minutes. After anaesthesia induction and full neuromuscular blockade, tracheal intubation is performed and mechanical ventilation is started. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult, ≥18 years old
- ASA 1-2
- BMI < 30
- Planned for elective laryngeal surgery
Key exclusion criteria (7 listed)
- NYHA-class >1
- Pregnancy
- Severe gastric reflux
- Neuromuscular disease
- Any pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apnoeic oxygenation with high-flow nasal oxygenThe subjects in the intervention group will be oxygenated with HFNO during the surgical procedure. | Device | Apnoeic oxygenation with High-flow nasal oxygen |
| Mechanical ventilationStudy subjects in the comparator group will be tracheally intubated and mechanically ventilated | Other | Mechanical ventilation |
Primary outcome
Significant haemodynamic effects during apnoeic oxygenation with HFNO
Time frame: 3 hours
Significant haemodynamic effects such as significant increase in mPAP and/or new echocardiographic signs of right ventricular strain or failure compared to baseline, during and up to 2 hours after apnoeic oxygenation with HFNO or mechanical ventilation.
4 secondary outcomes
Alterations in FloTrac derived central haemodynamic parameters
Time frame: 3 hours
Alterations in Electrocardiogram
Time frame: 3 hours
Alterations in arterial carbon dioxide, oxygen and pH
Time frame: 3 hours
Alterations in blood catecholamines and cardiac biomarkers
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malin Jonsson Fagerlund principal investigator
Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apnoeic oxygenation with high-flow nasal oxygen and Mechanical ventilation in people with Laryngeal Disease, run by Region Stockholm at 1 site in Sweden.
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 4 inclusion and 7 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 15 May 2026. 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 Sweden. 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?
Significant haemodynamic effects during apnoeic oxygenation with HFNO (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2026.