## Protocol Section
### Identification Module
**NCT ID:** NCT06421012

**Acronym:** POXTRA

**Brief Title:** Preoxygenation for Tracheal Aspirations in Intensive Care

**Official Title:** Preoxygenation for Tracheal Aspirations in Intensive Care, a Randomized Controlled Trial

#### Organization Study ID Info
**ID:** APHP230486
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**Domain:** ANSM
**ID:** 2023-A00694-41
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-09-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-07-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator.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 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.

**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, i.e., 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 and/or disconnecting the patient from the ventilator.

Today, 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 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 1.1, i.e. an increase of 10% of deep desaturations.

The main analysis will be performed on the per-protocol population (more conservative in non-inferiority trials).The 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 patient's 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).

### Conditions Module

**Conditions:**

- ICU Patients Under Invasive Mechanical Ventilation

**Keywords:**

- Endotracheal suctioning

- Preoxygenation

- Ventilation

- ICU

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 2260

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Experimental : Patients without additional preoxygenation

**Label:** Patients without additional preoxygenation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: Active Comparator : Patients with additional preoxygenation

**Label:** Patients with additional preoxygenation

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients without additional preoxygenation

**Description:** Throughout the entire period of their mechanical ventilation, patients will not receive additional preoxygenation before any endotracheal suctioning; their FiO2 value will be maintained constant

**Name:** Experimental : Patients without additional preoxygenation

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Patients with additional preoxygenation

**Description:** Throughout the entire period of their mechanical ventilation, patients will receive additional preoxygenation at 100% FiO2 for a systematic 2-minute duration prior to any endotracheal suction. Subsequently, the FiO2 will be reset to the previous default value.

**Name:** Active Comparator : Patients with additional preoxygenation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** It will be calculated for each patient as the number of suctioning leading to deep desaturation (SpO2 88% or less, and 85% or less for patients with chronic obstructive pulmonary disease COPD), divided by the total number of endotracheal suctioning throughout the period. Oxygen saturation values will be collected every minute during the 15 minutes post-suctioning. Endotracheal suctioning in patients already ventilated with 100% FiO2 started prior to the decision to aspirate will not be taken into account

**Measure:** Rate of suctioning leading to deep desaturation

**Time Frame:** from Day 0 to ventilator weaning, and at the latest Day 28

#### Secondary Outcomes

**Description:** It will be calculated for each patient as the number of suctioning leading to severe desaturation (SpO2 85% or less, and 80% or less for patients with COPD), divided by the total number of endotracheal suctioning throughout the period

**Measure:** Suctioning rate leading to severe desaturation

**Time Frame:** From Day 0 to ventilator weaning, and at the latest Day 28

**Description:** Number of days without ventilation. In case of death value will be set to zero

**Measure:** Number of ventilator free days at D28

**Time Frame:** From Day 0 to Day 28

**Description:** Ventilator-associated pneumonia, as defined by the Formalized Recommendation of Experts from the SFAR-SRLF in 2017

**Measure:** Ventilator-associated pneumonia

**Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28

**Description:** Delirium occurring in ICU, defined by a positive result on the CAM-ICU clinical assessment tool specific to ICU delirium

**Measure:** Intensive care delirium

**Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28

**Description:** Composite criteria including at least one of the following: ischemic stroke, myocardial infarction, digestive ischemia

**Measure:** Composite criteria of ischemic phenomena in ICU, including one of the following: stroke, myocardial infarction, digestive ischemia

**Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28

**Description:** Ischemic stroke occurring in intensive care, defined by the combination of the onset of focal motor deficit and compatible cerebral imaging

**Measure:** Ischemic stroke

**Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28

**Description:** Myocardial infarction occurring in intensive care, defined by an acute coronary syndrome with ST segment elevation and troponin elevation

**Measure:** Myocardial infarction

**Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28

**Description:** Digestive ischemia occurring in intensive care, diagnosed by CT scan or digestive endoscopy

**Measure:** Digestive ischemia

**Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28

**Description:** Cardiac arrest occuring in intensive care

**Measure:** Cardiac arrest

**Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28

**Description:** Acute kidney injury occurring in intensive care, defined by the initiation of renal replacement therapy

**Measure:** Acute kidney injury

**Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28

**Description:** Time to first bowel movements

**Measure:** First bowel movements

**Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28

**Description:** Vital status at discharge from ICU

**Measure:** ICU discharge vital status

**Time Frame:** At ICU discharge and at the latest Day 90

**Description:** Vital status at discharge from hospital

**Measure:** Hospital discharge vital status

**Time Frame:** At hospital discharge, and at the latest Day 90

**Description:** Mean saturation over all the period of 15 minutes post suctioning

**Measure:** Mean saturation over 15 minutes post-suctioning

**Time Frame:** From Day 0 to ventilator weaning, and at the latest Day 28

**Description:** ARDS according to the Berlin definition, characterized by 1) acute respiratory failure evolving for a week or less, 2) bilateral opacities on thoracic imaging, 3) no evidence of predominant hydrostatic edema, 4) hypoxemia with a PaO2/FIO2 ratio \< 300 mmHg for positive end-expiratory pressure set at 5 cmH2O or more, with 3 severity stages defined based on hypoxemia

**Measure:** Acute respiratory distress syndrome (ARDS)

**Time Frame:** From Day 0 to hospital discharge, and at the latest Day 90

**Description:** Length of stay in intensive care

**Measure:** Length of ICU stay

**Time Frame:** at ICU discharge, and at the latest Day 90

**Description:** Length of stay in hospital

**Measure:** Length of hospital stay

**Time Frame:** at hospital discharge, and at the latest Day 90

**Description:** For each desaturation, time in minutes between endotracheal suctioning and desaturation

**Measure:** Time in minutes between endotracheal suctioning and eventual desaturation

**Time Frame:** From Day 0 to ventilator weaning, and at the latest Day 28

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18 years of age or older
* Hospitalized in ICU, under invasive mechanical ventilation for less than 24 hours
* Information and signature of consent by patient or relative/trusted person, or emergency inclusion procedure

Exclusion Criteria:

* Not affiliated to a social security system
* Pregnant
* Under legal protection (curatorship, guardianship or safeguard of justice)
* Patient under AME

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** claire.fazilleau@aphp.fr

**Name:** Claire FAZILLEAU

**Phone:** 01 42 16 22 75

**Role:** CONTACT

**Contact 2:**

**Email:** jean-michel.constantin@aphp.fr

**Name:** Jean Michel CONSTANTIN, Pr

**Phone:** 01 42 17 73 05

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** claire.fazilleau@aphp.fr

- **Name:** Claire FAZILLEAU

- **Phone:** 01 42 16 22 75

- **Role:** CONTACT

***Contact 2:***

- **Email:** jean-michel.constantin@aphp.fr

- **Name:** Jean Michel CONSTANTIN, Pr

- **Phone:** 01 42 17 73 05

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpital Pitié Salpêtrière

**Zip:** 75013

#### Overall Officials

**Official 1:**

**Affiliation:** Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

**Name:** Claire FAZILLEAU

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Researchers who provide a methodologically sound proposal.

**Description:** The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
