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OpenTrials
Completed

NCT Number: NCT02780466

Observational Study on Intubation in Septic Shock

Septic shock is common in intensive care and its mortality remains high. While new treatments have not improved survival, optimization of known and widely used techniques has allowed reduction in mortality. Thus improving care given to patients starts with making better use of existing resuscitation techniques. Among these practices, mechanical ventilation is widespread in the management of patients with septic shock. In large studies published in recent years in Europe and North America, 40 to 85% of patients receive invasive mechanical ventilation. It therefore appears that a significant proportion of patients are never intubated during treatment and management of their septic shock. There is no specific recommendation from critical care societies concerning mechanical ventilation in the treatment of septic shock. Apart from indisputable situations such as impaired consciousness or acute respiratoire distress, the decision whether to ventilate mechanically or not is left to the discretion of the physician.

The aim of this study is to analyze intubation practice in septic shock patients and its impact on 28-day survival.

This multicentric and observational study will be conducted in 30 French ICUs.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • older than 18 years old
  • Admitted in the ICU for septic shock
  • Introduction of vasopressors ( norepinephrine or adrenaline ) in the ICU or within 24 hours of ICU admission
  • Suspected or proven infection

Exclusion criteria

  • Intubation before the introduction of vasopressors
  • Decision of withdrawing or withholding care at admission
  • Pregnant woman
  • Patient not affiliated to the social security insurance
  • Refusal of participation in the study

Treatment and study plan

Primary outcomes

  1. death

    Time frame: 28 days after ICU admission

Secondary outcomes

  1. duration of organ support

    Time frame: 28 days

    mechanical ventilation, vasopressors, renal replacement therapy

  2. impact of intubation delay on outcome

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: INTUBATIC

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 23, 2016
Registry last updated
Apr 18, 2018

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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