Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery

NCT06316063 | Completed DMC

• 1 other identifier: 2023-
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Laryngeal Disease

Keywords

Apnoeic oxygenation; Pulmonary hypertension; High-flow nasal oxygen; Right ventricular function

Outcome Measures

Primary Outcomes (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.

  3 hours

Secondary Outcomes (4)

• Alterations in FloTrac derived central haemodynamic parameters

  3 hours

• Alterations in Electrocardiogram

  3 hours

• Alterations in arterial carbon dioxide, oxygen and pH

  3 hours

• Alterations in blood catecholamines and cardiac biomarkers

  3 hours

Study Arms (2)

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.

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.

Other: Mechanical ventilation

Interventions

Apnoeic oxygenation with high-flow nasal oxygen DEVICE

The subjects in the intervention group will be oxygenated with HFNO during the surgical procedure.

Apnoeic oxygenation with High-flow nasal oxygen

Mechanical ventilation OTHER

Study subjects in the comparator group will be tracheally intubated and mechanically ventilated

Mechanical ventilation

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, ≥18 years old
• ASA 1-2
• BMI \< 30
• Planned for elective laryngeal surgery

You may not qualify if:

• NYHA-class \>1
• Pregnancy
• Severe gastric reflux
• Neuromuscular disease
• Any pulmonary disease
• Not capable of understanding study information and signing a written consent

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

Location

MeSH Terms

Conditions

Laryngeal Diseases; Hypertension, Pulmonary

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Lung Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Malin Jonsson Fagerlund

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: March 25, 2024
• Primary Completion: November 26, 2024
• Study Completion: January 31, 2025
• Last Updated: April 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)