Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure

Phase 3

Completed

• Conditions: Hypotension and Shock; Anesthesia Intubation Complication; Respiratory Failure; Intubation Complication; Hypotension on Induction
• Interventions: Drug: Norepinephrine; Drug: Lactated Ringers, Intravenous; Drug: normal saline; Drug: Plasma-lyte

• Registration Number: NCT05355974
• Lead Sponsor: Wright State University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-02
• Study Start: 2022-08-09
• Status Verified: 2024-07
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-10
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norepinephrine plus Isotonic Fluids	Norepinephrine	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.
Norepinephrine plus Isotonic Fluids	Lactated Ringers, Intravenous	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.
Norepinephrine plus Isotonic Fluids	normal saline	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.
Isotonic Fluids	Lactated Ringers, Intravenous	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.
Isotonic Fluids	normal saline	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.
Isotonic Fluids	Plasma-lyte	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.
Norepinephrine plus Isotonic Fluids	Plasma-lyte	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.

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	1 hour after Rapid Sequence Intubation	Change in systolic blood pressure during rapid sequence intubation in mmHg.

Secondary Outcome Measures

Name	Time	Method
Change in serum creatinine (Acute Kidney Injury)	24 hours after Rapid Sequence Intubation	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
Acute Kidney Injury	24 hours after Rapid Sequence Intubation	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

Trial Locations

Locations (1)

Miami Valley Hospital Premier Health; 🇺🇸 Dayton, Ohio, United States