RecruitingNot ApplicableNCT05209737

Trendelenburg As a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients

Trendelenburg As a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients: a Pilot Randomized Controlled Trial

Sponsor

Negovsky Reanimatology Research Institute

Enrollment

50 participants

Start Date

Jan 31, 2022

Study Type

INTERVENTIONAL

Conditions

Hypotension Shock

Summary

A pilot randomized controlled trial to evaluate the efficacy and safety of Trendelenburg position in critically ill patients with hypotension, mainly patients with septic shock and post operative vasoplegia. The main aim is to assess whether Trendelenburg position can improve organ function through a reduction in the need of fluid infusion and dose of vasopressors. Patients will be screened for participation in the study and eventually randomized based on a balanced randomization scheme (1:1) to Trendelenburg position up to 72 hours after intensive care unit (ICU) admission or Semirecumbent position (standard of care).

Eligibility

Min Age: 18 Years

Inclusion Criteria10

Age >18 years
Admitted to the intensive care unit (ICU);
Invasive mechanical ventilation;
Pharmacological sedation;
Mean arterial pressure (MAP)<65 mmHg or need of fluids infusion or any vasopressor in order to keep MAP > 65 mmHg
Ongoing invasive and/or non-invasive arterial blood pressure monitoring
Central venous line with central venous pressure (CVP) monitoring
Naso-gastric tube in situ
Indwelling bladder catheter
Consent according to local ethical committee rules

Exclusion Criteria19

Body mass index > 45
Documented or suspected increased intracranial pressure, based on medical history or actual clinical condition (es. intracranial tumor, cerebral hemorrhage, encephalitis,...);
Intra-abdominal hypertension >25 mmHg
Documented or suspected increased intraocular pressure (any degree of glaucoma)
Full stomach pyloric incontinence;
Gastric stasis, defined as aspiration from the NG (nasogastric) tube of fecal, bloody, or green fluid greater than 100 mL upon insertion of the tube or within the preceding hour;
Ongoing enteral nutrition
No central line inserted or femoral central line only
Not sutured known diaphragm lesions
Known hiatus hernia
Aortic bifurcation and/or lower extremity arterial stenosis ≥70% combined with stage 3 intermittent claudication (pain at rest)
Patients who are not able to be investigated with a leg raising test (eg lower extremities fractures, backbone fractures or backbone pain or deformity, and those patients with large cannulas in the femoral vessels)
Demand of specific postures (eg Trauma, fractures, backbone pain or deformity, patients with large cannulas in the femoral vessels, pronation including first pronation planned within 6 h…)
Any device which, according to the clinician, makes it unfeasible or unsafe to put patients in the Trendelenburg position (eg Drainage in thoracic cavity)
Mechanical Circulatory Support;
(CHD) (Gleen, Fontaine);
Advanced right ventricular dysfunction or advanced cardiac failure, in which volume overload worsens cardiac function (plateau stage in the Frank-Starling curve);
Actual upper gastrointestinal bleeding
Passive leg raising test non-responder