Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421012
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-15
Brief Title:
Preoxygenation for Tracheal Aspirations in Intensive Care
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Preoxygenation for Tracheal Aspirations in Intensive Care a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
POXTRA
Brief 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by the ventilator 2-3 minutes before the procedure These longstanding recommendations were reiterated in 2022 based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator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 patients 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
Currently suctioning are performed on-demand based on the patients 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
Detailed Description:
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 Endotracheal suctioning are performed when the patient is unable to clear the airways of obstructions hindering the free passage of air Classically endotracheal suctioning cause transient desaturation exacerbated by a decrease in cardiac output due to an increase in mean arterial pressure promoting cardiac arrhythmias To minimize these effects it is recommended to perform additional preoxygenation ie 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 andor disconnecting the patient from the ventilator
Today suctioning are performed on-demand based on the patients congestion status either through the endotracheal tube cap or a closed system Desaturations have become rare without establishing that additional preoxygenation can prevent them Moreover additional preoxygenation is not without risks In the short term it induces de-nitrogenation atelectasis resulting in a loss of lung volume that can worsen pre-existing lung injuries in the most severe patients In less severe cases preoxygenation is responsible for transient hyperoxia with various deleterious effects impacting patient prognosis Thus a short-term risk such as deep desaturations is juxtaposed with a medium-term risk of hyperoxia and de-nitrogenation
The investigators hypothesize that the absence of additional preoxygenation is not inferior in terms of deep desaturations to the strategy with additional preoxygenation and it would avoid exposing patients to the risks of de-nitrogenation-induced atelectasis and hyperoxia
The investigators retained a margin of non-inferiority for the relative risk of 11 ie an increase of 10 of deep desaturations
The main analysis will be performed on the per-protocol population more conservative in non-inferiority trialsThe per-protocol population will include patients who had at least one suctioning and for whom the additional preoxygenation strategy allocated by randomisation was followed in at least 70 of all suctioning reported in the patients care record Patients who stopped their participation in the study before endpoint timeframe and those who had never had an suctioning will not be included in the per protocol population
The unit of analysis will be the patient and a rate of suctioning leading to deep desaturation will be calculated for each patient as described in the primary endpoint The mean rate of suctioning leading to deep desaturation will then be calculated by treatment group with additional preoxygenation without additional preoxygenation
Today suctioning are performed on-demand based on the patients congestion status either through the endotracheal tube cap or a closed system Desaturations have become rare without establishing that additional preoxygenation can prevent them Moreover additional preoxygenation is not without risks In the short term it induces de-nitrogenation atelectasis resulting in a loss of lung volume that can worsen pre-existing lung injuries in the most severe patients In less severe cases preoxygenation is responsible for transient hyperoxia with various deleterious effects impacting patient prognosis Thus a short-term risk such as deep desaturations is juxtaposed with a medium-term risk of hyperoxia and de-nitrogenation
The investigators hypothesize that the absence of additional preoxygenation is not inferior in terms of deep desaturations to the strategy with additional preoxygenation and it would avoid exposing patients to the risks of de-nitrogenation-induced atelectasis and hyperoxia
The investigators retained a margin of non-inferiority for the relative risk of 11 ie an increase of 10 of deep desaturations
The main analysis will be performed on the per-protocol population more conservative in non-inferiority trialsThe per-protocol population will include patients who had at least one suctioning and for whom the additional preoxygenation strategy allocated by randomisation was followed in at least 70 of all suctioning reported in the patients care record Patients who stopped their participation in the study before endpoint timeframe and those who had never had an suctioning will not be included in the per protocol population
The unit of analysis will be the patient and a rate of suctioning leading to deep desaturation will be calculated for each patient as described in the primary endpoint The mean rate of suctioning leading to deep desaturation will then be calculated by treatment group with additional preoxygenation without additional preoxygenation
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00694-41 | OTHER | ANSM | None |