Clinical trial NCT02780466: Observational Study on Intubation in Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Keywords: Septic shock
Endotracheal intubation
Outcome
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-05-23
Enrollment: 859
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: death
timeFrame: 28 days after ICU admission
Secondary outcomes:
measure: duration of organ support
timeFrame: 28 days
measure: impact of intubation delay on outcome
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.