Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events. The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.

Detailed Description
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Aim: Prevent 25-46 percent reduction in systolic blood pressure associated with rapid sequence intubation with norepinephrine compared to isotonic fluids alone.

Official Title
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Vasopressor Utilization to Support Mean Arterial Pressure During Rapid Sequence Intubation: A Clinical Trial (Rapid-Press Trial)

Conditions
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Respiratory Failure, Hypotension and Shock, Hypotension on Induction, Intubation Complication, Anesthesia Intubation Complication

Intervention / Treatment
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* Drug: Norepinephrine
* Drug: Lactated Ringers, Intravenous
* Drug: normal saline
* Drug: Plasma-lyte


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Respiratory Failure Requiring Intubation Exclusion Criteria: Pregnancy Patients intubated during code blue clinical scenarios Requiring surgical airway Failed intubations MAP less than 65 or Systolic Blood Pressure (SBP) less than 90mmHg pre-intubation Systolic blood pressure greater than 150mmHg Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norepinephrine plus Isotonic Fluids<br>The treatment group will receive a continuous infusion of norepinephrine at 0.10 mcg/kg/min started 2-5 minutes prior to Rapid Sequence Intubation (assuming normal systolic blood pressure 90-140mmHg) in addition to a standard fluid bolus of Lactated Ringers or Normal Saline or Plasmalyte at 999 mL/hr. | Drug: Norepinephrine<br>* Norepinephrine continuous infusion at 0.10 mcg/kg/min<br>* Other names: Norepinephrine-Dextrose;Drug: Lactated Ringers, Intravenous<br>* 500mL infusion run at 999mL/hr<br>* Other names: LR;Drug: normal saline<br>* 500mL infusion run at 999mL/hr<br>* Other names: 0.9 percent Sodium Chloride;Drug: Plasma-lyte<br>* 500mL infusion run at 999mL/hr<br>* Other names: Plasmalyte;|
| Active Comparator: Isotonic Fluids<br>The control group will receive an infusion of Lactated Ringers or Normal Saline or Plasma-Lyte with at least 500 mL at 999 ml/hr 2-5 minutes prior to Rapid Sequence Intubation. | Drug: Lactated Ringers, Intravenous<br>* 500mL infusion run at 999mL/hr<br>* Other names: LR;Drug: normal saline<br>* 500mL infusion run at 999mL/hr<br>* Other names: 0.9 percent Sodium Chloride;Drug: Plasma-lyte<br>* 500mL infusion run at 999mL/hr<br>* Other names: Plasmalyte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | Change in systolic blood pressure during rapid sequence intubation in mmHg. | 1 hour after Rapid Sequence Intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum creatinine (Acute Kidney Injury) | Change in serum creatinine (in mL) after rapid sequence intubation and development of Acute Kidney Injury as defined by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours | 24 hours after Rapid Sequence Intubation | 
| Acute Kidney Injury | Change in urine output (in mL) after rapid sequence intubation and development of Acute Kidney Injury as defined by Urine volume <0.5 mL/kg/hour for six hours | 24 hours after Rapid Sequence Intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mean arterial pressure, Rapid Sequence Intubation, vasopressor, Norepinephrine, Hypotension from Intubation