Pure Global

Preoxygenation for Tracheal Aspirations in Intensive Care - Trial NCT06421012

Access comprehensive clinical trial information for NCT06421012 through Pure Global AI's free database. This phase not specified trial is sponsored by Assistance Publique - Hôpitaux de Paris and is currently Not yet recruiting. The study focuses on ICU Patients Under Invasive Mechanical Ventilation. Target enrollment is 2260 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT06421012
Not yet recruiting
procedure
Trial Details
ClinicalTrials.govNCT06421012
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Preoxygenation for Tracheal Aspirations in Intensive Care
Preoxygenation for Tracheal Aspirations in Intensive Care, a Randomized Controlled Trial

Study Focus

Experimental : Patients without additional preoxygenation

Interventional

procedure

Sponsor & Location

Assistance Publique - Hôpitaux de Paris

Paris, France

Timeline & Enrollment

N/A

Jun 10, 2024

Sep 10, 2027

2260 participants

Primary Outcome

Rate of suctioning leading to deep desaturation

Summary

Clearing the airways is a complex phenomenon involving the production of secretions, the
 nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and
 coughing. In intubated and ventilated patients, endotracheal suctioning occur when the
 patient is unable to clear the airways of obstructions hindering the free passage of air.
 These suctioning can lead to transient desaturation exacerbated by a decrease in cardiac
 output due to increased mean arterial pressure, promoting cardiac arrhythmias. To minimize
 these effects, it is recommended to perform additional preoxygenation, by increasing the
 fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the
 procedure. These longstanding recommendations were reiterated in 2022, based on outdated
 studies involving systematic suctioning that required disconnecting the patient from the
 ventilator.
 
 Currently, suctioning are performed on-demand, based on the patient's congestion status,
 either through the endotracheal tube cap or a closed system. Desaturations have become
 infrequent without establishing that additional preoxygenation can prevent them. Moreover,
 additional preoxygenation is not without risks. By inducing de-nitrogenation atelectasis with
 a loss of lung volume, it can exacerbate pre-existing lung injuries in the most severe
 patients. In less severe cases, preoxygenation leads to transient hyperoxia, with various
 deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep
 desaturations, must be balanced against a medium-term risk of hyperoxia and de-nitrogenation.

ICD-10 Classifications

Acute pulmonary insufficiency following nonthoracic surgery
During unspecified surgical and medical care
During unspecified surgical and medical care
During unspecified surgical and medical care
During other surgical and medical care

Data Source

ClinicalTrials.gov

NCT06421012

Non-Device Trial