Observational Study on Intubation in Septic Shock (INTUBATIC)

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock

• Study Type: Observational
• Enrollment (Actual): 859

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the study are adults patients admitted to intensive care unit in France (about 30 centers) for shock, supposed or confirmed of septic origin.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with septic shock

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
death	28 days after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of organ support	mechanical ventilation, vasopressors, renal replacement therapy	28 days
impact of intubation delay on outcome		28 days

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Publications and helpful links

General Publications

• Mellado-Artigas R, Ferrando C, Martino F, Delbove A, Ferreyro BL, Darreau C, Jacquier S, Brochard L, Lerolle N. Early intubation and patient-centered outcomes in septic shock: a secondary analysis of a prospective multicenter study. Crit Care. 2022 Jun 7;26(1):163. doi: 10.1186/s13054-022-04029-6.
• Darreau C, Martino F, Saint-Martin M, Jacquier S, Hamel JF, Nay MA, Terzi N, Ledoux G, Roche-Campo F, Camous L, Pene F, Balzer T, Bagate F, Lorber J, Bouju P, Marois C, Robert R, Gaudry S, Commereuc M, Debarre M, Chudeau N, Labroca P, Merouani K, Egreteau PY, Peigne V, Bornstain C, Lebas E, Benezit F, Vally S, Lasocki S, Robert A, Delbove A, Lerolle N. Use, timing and factors associated with tracheal intubation in septic shock: a prospective multicentric observational study. Ann Intensive Care. 2020 May 24;10(1):62. doi: 10.1186/s13613-020-00668-6.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Septic shock; Outcome; Endotracheal intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 2015-96