Phase 4
N=337
Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation
Acute Respiratory Failure · Intubation Complication
Bottom Line
View on ClinicalTrials.gov: NCT03026777 ↗Enrolled (actual)
337
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Participants With Cardiovascular Collapse — 33; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- intravenous crystalloid fluid, 500 mL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Cardiovascular Collapse |
33; 31 | — |
| SECONDARY In-hospital Mortality |
48; 59 | — |
| SECONDARY Ventilator-free Days |
20; 19 | — |
| SECONDARY ICU-free Days |
16; 14 | — |
| SECONDARY Lowest Arterial Oxygen Saturation |
94; 95 | — |
| SECONDARY Number of Laryngoscopy Attempts |
1; 1 | — |
| SECONDARY Lowest Systolic Blood Pressure |
119; 119 | — |
Summary
Endotracheal intubation is common in the care of critically ill patients. Complications of airway management in this setting are frequently encountered and may be associated with an increased risk of death. The prevention of complications during urgent and emergent endotracheal intubation is a key focus for airway management research. Post-intubation hypotension (PIH), a common complication of endotracheal intubation in the critically ill, may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but this approach has not been examined in a prospective trial. There are no randomized trials of intravenous fluid administration to prevent PIH in critically ill adults. The investigators propose a randomized trial of fluid loading to prevent PIH in critically ill adults.
Eligibility Criteria
Inclusion Criteria
- Patient is admitted to participating study unit
- Planned procedure is endotracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- Administration of sedation with or without neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria
- Operator believes fluid loading to be absolutely indicated or contraindicated for the safe care of the patient
- Urgency of intubation precludes safe performance of study procedures
- Pregnancy
- Prisoners
- Age < 18 years old
Data sourced from ClinicalTrials.gov (NCT03026777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.