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Completed

NCT Number: NCT01014299

Recruitment Maneuver After Intubation

The purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver immediately after intubation in hypoxemic patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

In the intensive care unit (ICU), acute respiratory failure is a common problem. Airway management in critically ill patients usually requires endotracheal intubation after rapid sequence induction. Induction of anesthesia is a well known cause of dramatic changes in respiratory mechanics and gas exchange. Moreover, when the intubation is for respiratory failure, the underlying pathology increases these modifications. The reduction in lung volume results in a deep hypoxemia after intubation. Moreover, mechanical ventilation applied on a collapsed lung increases the risk of ventilator induced lung injury. Recruitment maneuver, which consists of a transient increased in inspiratory pressure, decreases anesthesia-induced lung collapse and hypoxemia. During early acute respiratory failure, RM increases oxygenation and lung volume and may reduce lung oedema. Some authors have suggested the potential benefit of an early RM after induction of anesthesia in operating room. To date, no study has evaluated the short term effect of a recruitment maneuver performed early after intubation in critically ill patients. Therefore, our aim was to ascertain whether RM, performed immediately after intubation, is safe and more effective at reducing hypoxemia than usual management, in hypoxemic patients requiring intubation for invasive ventilation in the ICU.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adults who met acute respiratory failure requiring intubation
  • adults who met hypoxemia, defined by a PaO2 less than 100 mm Hg under a high FiO2 mask driven by at least 10 L/min oxygen.

Exclusion criteria

  • encephalopathy
  • coma
  • cardiac resuscitation
  • hyperkaliemia (>5.5 mEq/L)
  • acute brain injury and recent thoracic surgery

Treatment and study plan

recruitment maneuver

Other

Assigned interventions:

  • No intervention after tracheal intubation (control group)
  • Alveolar recruitment maneuver (RM group) immediately after intubation

Primary outcomes

  1. Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation

    Time frame: 5 min after the onset of mechanical ventilation

Secondary outcomes

  1. PaO2 at 30 min after intubation, hemodynamic and microbiologic safety, ICU length of stay, ICU mortality and mechanical ventilation duration.

    Time frame: at 30 min after intubation

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Recruitment Maneuver Increases Oxygenation After Intubation in Hypoxemic ICU Patients: a Randomized Controlled Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 16, 2009
Registry last updated
Nov 25, 2009

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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