Oxygen with different flow rates during the placement of the ventilation tube in newborns and infants - a multicenter, non-inferiority, prospective, randomized controlled study

Zusammenfassung der Studie

Oxygen is vital for survival. With each breath, our body is supplied with it. However, during general anesthesia, autonomous breathing (so-called apnea) is stopped. Particularly in infants and newborns, lack of oxygen can lead to hypoxia and cardiac arrest in a very short time. To prevent this, patients under general anesthesia are ventilated with a ventilation mask until the ventilation tube is placed in the trachea (so-called intubation) and artificial ventilation is started via a ventilator. During the actual placement of the ventilation tube, ventilation with the ventilation mask is not possible. • In previous studies, we have shown that the administration of additional oxygen via a nasal cannula without autonomous breathing (so-called apneic oxygenation) significantly prolongs the time until hypoxia occurs in the body. However, it is currently unclear what the flow rate of the oxygen should be. • The aim of the study is to investigate the optimal oxygen flow rate during the placement of the ventilation tube into the trachea of newborns and infants in the operating room. To do this, we compare a low and a high oxygen flow rate during apnea. These two flow rates have been shown to be safe and effective in previous studies.

(BASEC)

Untersuchte Intervention

At the beginning, the procedure is the same as for any operation. The children are received by a specialized anesthesia team. A sensor for measuring oxygen in the blood is attached to the child's finger or toes, a blood pressure cuff is placed on the arm, and electrodes for cardiac monitoring are attached to the chest. The anesthesia team will establish venous access. Anesthesia will be started with the usual medications after oxygen has been administered to the child for 1 minute. The child will be ventilated for one minute with a ventilation mask until all medications have taken full effect. Meanwhile, the study team will open an envelope to learn the random assignment of your child.

Low oxygen flow: 100% oxygen, flow rate 0.2 L/kg/min, conventional nasal cannula

or

High oxygen flow: 100% oxygen, flow rate 2 L/kg/min with Optiflow device.

Once the oxygen supply is installed, intubation will be performed with a laryngoscope with camera (videolaryngoscopy). This corresponds to the standard procedure. After the placement of the ventilation tube in the trachea, the study is completed and the intervention or examination can begin. If the placement of the ventilation tube in the trachea fails on the first attempt, a maximum of two additional attempts will be made. In this case, the anesthesia team is free to change the oxygen flow rate and/or perform the placement of the ventilation tube in the trachea with another device. If the placement of the ventilation tube in the trachea continues to be unsuccessful, we will follow the standardized treatment pathway for a difficult airway. In all cases, the data and measurements will be recorded, and the child will be visited 24 hours after the operation by an anesthesiologist to identify any complications.

(BASEC)

Untersuchte Krankheit(en)

The aim of this study is to investigate the optimal oxygen flow rate required during intubation with the C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) in the operating room or in the intensive care unit. We assume that the difference between low-flow and high-flow oxygen supply is negligible.

(BASEC)

Sponsor

Inselspital Bern

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Bern

(BASEC)

Datum der Bewilligung durch die Ethikkommission

10.07.2023

(BASEC)

Ergebnisse der Studie