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Completed

NCT Number: NCT05423301

Global Physiotherapy in ICU Patients With High Risk Extubation Failure

This study aims to compare care provided by physiotherapists, combining respiratory care and early rehabilitation in intensive care unit, with standard care on the rate of acute respiratory failure within 7 days after extubation, in patients with high risk of extubation failure.

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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - Hopital Haut-Lévêque

Pessac, 33604, France

About this study

The extubation failure rate is 15% on average in intensive care units, but can reach 30% within 48 hours after extubation in high risk patients. Their characteristics are : age > 65 years, respiratory disease, body mass index > 30 kg / m², intubation for more than 7 days, first extubation failure, and patient with ineffective cough associated with bronchial obstruction. The main reason for reintubation in these patients is acute respiratory failure with an ineffective cough, a bronchial obstruction, and neuromyopathy. On these three components, the physiotherapist can apply specific techniques. Even though scientific literature recommends the presence of a physiotherapist before, during and after extubation in patients intubated for more than 48 hours, the benefits of physiotherapy in this context remains poorly explored.

The main objective of this study is to compare the rate of acute respiratory failure within 7 days post-extubation in high-risk intensive care patients. The secondary objectives are to compare the ROX index, the reintubation rate for acute respiratory failure within 7 days after extubation, the rate of pneumonia at 7 days, time spent on respiratory and mobilization care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with spontaneous ventilation weaning test.
  • Consent form signed by the person support.

Exclusion criteria

  • Patients with a self-extubation,
  • Patients with a tracheostomy,
  • Patients with acute respiratory failure for acute lung edema (OAP),
  • Patients with decision to limit or stop Active Therapeutics (LATA).

Treatment and study plan

Experimental

Procedure

Respiratory care consists of manual and instrumental bronchial clearance techniques: Expiratory Flow Enhancement (EFE), suctioning, manual cough assist techniques, instrumental clearance techniques (suctioning and Cough Assist) and swallowing disorder management.)

Control

Procedure

The control group will receive early respiratory care and rehabilitation by nurses, nurses' aides and doctors until D7. Respiratory care includes aerosol therapy, oral and pharyngeal clearance with aspirations, verbal coughing and sputum removal, and possibly bronchial fibroscopy for clearance if necessary. Early rehabilitation consists of alternating postures in bed, passive chair positioning (patient lift), or active positioning via a bed rail and standing.

Primary outcomes

  1. Rate of acute respiratory failure

    Time frame: During 7 days post extubation

    The primary endpoint is the proportion of patients with post-extubation acute respiratory failure, defined as the occurrence within 7 days of extubation of at least two of the following criteria: respiratory acidosis (pH <7.35, PaCO2 >45 mmHg), hypoxemia (PaO2 <60 mmHg with a FiO2 >40% or PaO2/FiO2<150) and respiratory rate >35/min.

Secondary outcomes

  1. ROX index

    Time frame: 8 hours during 7 days post extubation

    ROX index is calculated every 8 hours during the 7 days post-extubation, ROX index is defined by the ratio of oxygen saturation measured by pulse oximetry/FiO2 to respiratory rate.

  2. Rate of reintubation

    Time frame: During 7 days post extubation

    The rate of reintubation within 7 days post-extubation, with reintubation occurring contemporaneously with the onset of acute respiratory failure, without expected clinical improvement,

  3. Rate of pneumopathy

    Time frame: During 7 days post extubation

    Lung disease is defined by the following criteria:

    o Radiological signs : Two successive films from which the appearance of a focus of lung disease is suspected, If there is no history of heart or lung disease: one scan is sufficient.

    o At least one of the following signs: temperature > 38.5° without other cause leukocytes < 4000/mm3 or > 12000/mm3

    o And at least two of the following signs: Purulent secretions Cough or dyspnoea Desaturation or increased oxygen requirement or need for ventilatory support

  4. Time for respiratory care

    Time frame: During 7 days post extubation

    The mean time spent on respiratory care or mobilisation of patients estimated daily in the 7 days following extubation. Time estimated in minutes.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Impact of Global Physiotherapy on Acute Respiratory Failure Within 7 Days After Extubation in Intensive Care Unit Patients With High Risk of Extubation Failure.

Acronym: KINEXTUB

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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