Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2024-07-10

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Norepinephrine plus Isotonic Fluids

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.

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

Norepinephrine continuous infusion at 0.10 mcg/kg/min

Lactated Ringers, Intravenous

Intervention Type DRUG

500mL infusion run at 999mL/hr

normal saline

Intervention Type DRUG

500mL infusion run at 999mL/hr

Plasma-lyte

Intervention Type DRUG

500mL infusion run at 999mL/hr

Isotonic Fluids

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.

Group Type ACTIVE_COMPARATOR

Lactated Ringers, Intravenous

Intervention Type DRUG

500mL infusion run at 999mL/hr

normal saline

Intervention Type DRUG

500mL infusion run at 999mL/hr

Plasma-lyte

Intervention Type DRUG

500mL infusion run at 999mL/hr

Interventions

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Norepinephrine

Norepinephrine continuous infusion at 0.10 mcg/kg/min

Intervention Type DRUG

Lactated Ringers, Intravenous

500mL infusion run at 999mL/hr

Intervention Type DRUG

normal saline

500mL infusion run at 999mL/hr

Intervention Type DRUG

Plasma-lyte

500mL infusion run at 999mL/hr

Intervention Type DRUG

Other Intervention Names

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Levophed Norepinephrine Bitartrate Norepinephrine-Dextrose Ringer's Injection Hartmann's Solution LR NS 0.9 percent Sodium Chloride Plasma-Lyte 148 Plasmalyte

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No