Non-inferiority of a Strategy of Continuing Oral Intake Compared With Fasting

NCT ID: NCT06510972

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 754 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-10-31

Brief Summary

Fasting in the intensive care unit is a crucial issue and has been studied in particular in patients on mechanical ventilation or at the time of weaning. To date, there are no data on fasting in patients with acute respiratory failure hospitalised in the intensive care unit but not intubated.

The nutritional attitude to adopt in these patients is not mentioned in the recommendations on nutrition for intensive care patients, even though it has been proven in the literature that this specific category of patients does not achieve the theoretical calorie targets, particularly as a large proportion of these patients are not fed, whether orally (or per os), enteral via a naso- or oro-gastric tube or parenterally. There is therefore a real rationale for trying to maintain a nutritional intake in patients with acute respiratory failure.

One of the fears of the team caring for a patient in acute respiratory failure is the potential occurrence of false routes.

In addition to false routes, orotracheal intubation of patients requiring mechanical ventilation in intensive care presents a risk of inhalation of gastric contents followed by the potential development of pneumonia.

In the clinical setting, inhalation may not be symptomatic, but may progress to severe pneumonia and acute respiratory distress syndrome, pulmonary fibrosis and therefore be life-threatening.

By analogy, in intensive care, patients at risk of intubation are put on a fast as a preventive measure to limit the risk of a false route and the risk of potential inhalation in the event of intubation. This practice, which is very common on admission to intensive care and continuous care units, has not been studied in the literature and is not the subject of recommendations.

Finally, patients hospitalised in intensive care are subject to numerous discomforts.

The hypothesis put forward is that the continuation of intravenous fluids in intensive care units for patients at risk of intubation does not increase the need for intubation and does not increase adverse effects such as false routes or inhalation of gastric contents in patients who ultimately require intubation.

Conditions

Patient in Acute Respiratory Failure; Continuation of Oral Intake

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Strategy for continuing to take oral supplements

Patients will be able to ingest any type of liquid or solid food orally, at any frequency and in any quantity they wish, according to their tolerance, with paramedical assistance if necessary. The necessary treatments will be administered orally. The patient may benefit from a glucosed intake at the discretion of the practitioner in charge of the patient. The patient will benefit from regular mouth care. Intravenous and oral fluids will be quantified.

Group Type: EXPERIMENTAL

Strategy for continuing oral intake

Intervention Type: PROCEDURE

Patients will be able to ingest liquids or solid food orally, at any frequency and in any quantity they wish, according to their tolerance, with paramedical assistance if necessary.

Fasting strategy

The patient will not be able to ingest liquids or solid foods. The patient will be given glucose or parenteral nutrition at the discretion of the practitioner in charge of the patient. The patient will receive regular mouth care. Oral treatments that are essential and have no parenteral alternative may be administered under paramedical supervision.

Group Type: ACTIVE_COMPARATOR

Fasting strategy

Intervention Type: PROCEDURE

The patient will not be able to ingest liquids or solid food.

Interventions

Strategy for continuing oral intake

Patients will be able to ingest liquids or solid food orally, at any frequency and in any quantity they wish, according to their tolerance, with paramedical assistance if necessary.

Intervention Type: PROCEDURE

Fasting strategy

The patient will not be able to ingest liquids or solid food.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ 18 years old
• Participant affiliated to a social security scheme
• Express oral consent of the participant, or failing that of the trusted support person, or failing that of the next of kin
• Patient hospitalised in an intensive care unit or in a continuous surveillance unit or in an intensive care unit for less than 24 hours.
• Criteria for acute hypoxaemic respiratory failure defined as.

• Respiratory rate > 25 cpm or indifferent if SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) infection occurred ≥ 1 time since admission.
• PaO2/FiO2 < 200 mmHg or equivalent SpO2 (oxygen saturation)/FiO2 (fraction of inspired oxygen) i.e. < 235 (measured under at least 10 L/min high concentration mask)

Exclusion Criteria

• Patient with criteria for immediate intubation:

• Persistent or worsening respiratory failure (respiratory rate > 40/min, respiratory failure on physical examination, respiratory acidosis with pH (hydrogen potential ) < 7.25, copious tracheal secretions, hypoxia with SpO2 < 90% despite FiO2 > 80% for more than 5 minutes without technical dysfunction).
• Major haemodynamic failure (need for increasing vasopressor support with instability and hypoperfusion).
• Neurological failure (Glasgow score < 8).
• Cardiac or respiratory arrest
• Chronic lung disease: chronic obstructive pulmonary disease (GOLD grade 3 or 4: Global Initiative for Chronic Obstructive Lung Disease) or other chronic lung disease requiring long-term oxygen or ventilation (this does not include a patient undergoing continuous positive nocturnal pressure for sleep apnoea syndrome).
• Contraindications to oral nutrition: known previous swallowing problems or inability to swallow, digestive sutures, admission for inhalation pneumonia, exclusive parenteral nutrition, etc.
• Patients with a nasogastric or orogastric tube, a jejunostomy or a feeding ileostomy
• Patient already on invasive mechanical ventilation on admission
• Limitation of therapies including a decision not to intubate
• Incapacitated adult (guardianship or curators)
• Pregnant, parturient or breast-feeding women
• Tracheostomised patient
• Patient already included for the first time in this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr SZYCHOWIAK, MD

Role: STUDY_DIRECTOR

University Hospital, Orléans

Locations

Intensive care, University Hospital, Blois

Blois, , France

Intensive care, Hospital, Bourges

Bourges, , France

Intensive care, Hospital, Colombes

Colombes, , France

Intensive care, Hospital, Dreux

Dreux, , France

Intensive care, Hospital, La Roche sur Yon

La Roche-sur-Yon, , France

Intensive care, Hospital, Le MANS

Le Mans, , France

Intensive care, Hospital, Lille

Lille, , France

Intensive care, Hospital, Morlaix

Morlaix, , France

Intensive care, Hospital, Nantes

Nantes, , France

Intensive care, University Hospital, Orléans

Orléans, , France

Intensive care, University Hospital, Tours

Tours, , France

Countries

France

Central Contacts

Piotr SZYCHOWIAK, MD

Role: CONTACT

piotr.szychowiak@gmail.com

2.38.22.95.58 ext. +33

Facility Contacts

Julien GROUILLE, MD

Role: primary

Anna BOURREAU, MD

Role: primary

Damien ROUX, MCU-PH

Role: primary

Thomas JANSON, MD

Role: primary

Laureen GUILLEMIN, MD

Role: primary

Mickael LANDAIS, MD

Role: primary

Saadalla NSEIR, MD

Role: primary

Pierre-Yves EGRETEAU, MD

Role: primary

Jean REIGNIER, MCU-PH

Role: primary

Piotr SZYCHOWIAK, MD

Role: primary

Other Identifiers

DR230315

Identifier Type: -

Identifier Source: org_study_id