High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia (NCT03554863) | Clinical Trial Compass
CompletedNot Applicable
High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia
France60 participantsStarted 2018-11-21
Plain-language summary
Preoxygenation remains an important determinant of morbidity and mortality in anesthesia despite advances in mask ventilation and difficult intubation management.
1. The usual practice Preoxygenation prior to the injection of the anesthetic agents is the administration of pure oxygen to delay the occurrence of hypoxemia during the apnea phase and intubation maneuvers. It consists of applying a mask on the patient's face and allowing it to ventilate, ensuring a perfect seal of the device. The end of oxygen exhalation fraction is a good reflection of the alveolar oxygenation and a value of 95% corresponds to a "total" alveolar oxygenation. When this value is reached, the injection of the anesthetic agents (hypnotic, morphine and myorelaxant) leads to the loss of consciousness and apnea, which forces to continue the manual ventilation to the mask. Intubation is performed when the myorelaxation is complete.
2. Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal Oxygen.
The hypothesis of this study is that Humidified High-Flow Nasal Oxygen, should allow anesthetic induction without having to impose the patient the establishment of a facial mask for several minutes before anesthetic induction and the doctor anesthetist assisted ventilation with the mask before intubation.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Consent for participation
* Affiliation to the french social security system
* Patients benefit general anesthesia with oral intubation
Exclusion Criteria:
* Pregnant or breastfeeding patients;
* Patients with difficulty of ventilation by Optiflow AnesthesiaTM (facial trauma);
* Patients under the protection of justice
* Patients with drained or undrained pneumothorax;
* Patients with a predicted difficulty of mask ventilation or intubation according to the clinical examination prior to inclusion (arne score ≥ 11) or when treating the patient in the operating room;
* Patients with coronary heart disease, heart failure or respiratory failure;
* Patients with intracranial pathology; patients with arterial oxygen saturation \<95% in the open air;
* Patients for whom the surgical procedure requires the installation of a double-lumen tube;
* Patients requiring rapid sequence induction; patients for whom the induction can not be carried out by the sequence sufentanil, propofol, rocuronium;
* Patients with sugammadex allergy;
* Patients placed under judicial protection
* Patients who have already been included in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recourse to another ventilation technique
Timeframe: During the preoxygenation-induction-intubation period (30 min)