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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Sweden1 site
  • Karolinska Universitetssjukhuset Huddinge

    Stockholm

Other trials in Sweden

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.

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 groups in NCT06316063
Study groupRoleWhat they receive
Apnoeic oxygenation with High-flow nasal oxygenExperimentalIn 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 ventilationActive comparatorIn 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.

  1. 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)
  1. 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

  2. Alterations in Electrocardiogram

    Alterations in electrocardiogram during and up to 2 hours after apnoeic oxygenation with HFNO or mechanical ventilation.

    Measured: 3 hours

  3. 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

  4. 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.

  1. First posted18 Mar 2024
  2. Study start25 Mar 2024
  3. Primary completion26 Nov 2024
  4. Study completion31 Jan 2025

Resources

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)
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

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.

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