Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316063
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-03-12
Brief Title:
Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery - a Randomised Study
Sponsor:
Region Stockholm
Organization:
Region Stockholm
Study Overview
Official Title:
Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery - a Randomised Study
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPOX
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
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 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 Lmin 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 Lmin 100 O2 Apnoea will be discontinued if any of the criteria SpO2 90 PaCO2 11 kPa pH 715 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 mlkg ideal body weight FiO2 04 and the respiratory frequency adjusted to reach a PaCO2 of 50 -53 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
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 Lmin 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 Lmin 100 O2 Apnoea will be discontinued if any of the criteria SpO2 90 PaCO2 11 kPa pH 715 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 mlkg ideal body weight FiO2 04 and the respiratory frequency adjusted to reach a PaCO2 of 50 -53 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None