Trial record 8 of 1398 for:    "Mayo Clinic" [Exact]

Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2015 by Mayo Clinic
Sponsor:
Collaborators:
Berkshire Medical Center, Pittsfield
Bridgeport Hospital
Detroit Medical Center
Essentia Health, Fargo
Geisinger Clinic
Marshfield Clinic Research Foundation
Memorial Hospital of Rhode Island
Mercy Hospital. Saint Louis
Ohio State University
University of North Carolina
UPMC at Hamot
Information provided by (Responsible Party):
Nathan J. Smischney, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02508948
First received: July 21, 2015
Last updated: July 23, 2015
Last verified: July 2015
  Purpose

To further examine current intubation practice among critically ill patients who are in need of endotracheal intubation, the investigators plan to perform a prospective cross-sectional study of adult critically ill patients who needed endotracheal intubation at participating sites between August 1st, 2015 to August 1st, 2016. The investigators aim to describe the current intubation practice among the participating sites with a description of complications that may have surfaced during the peri-intubation period and to isolate predictive factors of these complications.

In this study, the primary aim is to describe, through a prospective cross-sectional study, the current intubation practice of adult critically ill patients undergoing endotracheal intubations with secondary aims exploring complications that may emerge during the peri-intubation period and to isolate predictive factors of these complications. This information will generate hypotheses which will lead to further study with the ultimate impact of reducing patient-related outcomes such as morbidity and mortality.


Condition
Tracheal Intubation Morbidity

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Current State of Endotracheal Intubation Among the Critically Ill and Exploring Risk Factors for Immediate Complications of Endotracheal Intubation: a Prospective, Observational Multi-center Study (HEMAIR)

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of participants with Hypoxemia with in 30 minutes from intubation [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Number of participants with hypotension with in 30 minutes from intubation [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total days on mechanical ventilation during 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Total days of ICU/hospital length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of participants with vital status (dead/alive) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of participants with disposition to home, nursing home or long term care facility [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: August 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Aim 1: To describe the current intubation practice among the participating sites by collecting data on both airway management and hemodynamics during the peri-intubation period defined as 60 minutes pre- and post-intubation in adult critically ill patients.

Aim 2: To report the incidence of immediate (within 30 minutes after intubation) complications defined as the following: 1) cardiac arrest or death; 2) cardiovascular collapse (defined as a sustained decrease (>30 minutes) in mean arterial pressure < 65 mmHg or systolic arterial pressure < 90 mm Hg despite 1000-2000 liters of fluid loading [crystalloid and/or colloid solution] and/or the requirement of any vasoactive agent); 3) hypoxemia (decrease in pulse oximetry to oxygen saturation < 90% during attempts); 4) hypotension (mean arterial pressure <65 mmHg or systolic blood pressure < 90 mmHg occurring at any time); 5) difficult intubation (three or more attempts at laryngoscopy to place the endotracheal tube into the trachea and/or >10 minutes using conventional laryngoscopy and/or the need for another operator); 6) aspiration; 7) esophageal intubation [immediate and delayed]; 8) dental injury; 9) and supraventricular or ventricular arrhythmia (without loss of pulse); 10) vomiting; 11) oral or laryngeal trauma; 12) laryngospasm; 13) pneumothorax; 14) malignant hyperthermia; 15) medication error; 16) mainstem intubation; 17) nasal bleeding; 18) other.

Aim3: To isolate predictive factors of immediate airway (hypoxemia/difficult intubation) and hemodynamic (cardiovascular collapse/hypotension) complications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients admitted to 10-25 participating medical/surgical/mixed ICUs who underwent endotracheal intubation.

Criteria

Inclusion Criteria:

  • Patient age ≥ 18 years
  • Surgical and medical intensive care unit adult patients
  • Adult patients requiring endotracheal intubation during the time period of August 1st 2015 to August 1st 2016.

Exclusion Criteria:

  • Patient age < 18 years
  • Endotracheal intubations performed outside the ICU (in the operating room, in and outside the hospital) are excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02508948

Contacts
Contact: Nathan J Smischney, MD 507-255-6051 ext 56051 smischney.nathan@mayo.edu
Contact: Rahul Kashyap, MBBS 507-255-7196 ext 57196 kashyap.rahul@mayo.edu

Locations
United States, Arizona
Mayo Clinic, Scottsdale Not yet recruiting
Scottsdale, Arizona, United States, 85054
Contact: Ayen Sen, MD       sen.ayen@mayo.edu   
United States, Florida
Mayo Clinic, Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Pablo Moreno, MD       morenofranco.pablo@mayo.edu   
United States, Massachusetts
Cynthia Callahan,Berkshire Medical Center Not yet recruiting
Pittsfield, Massachusetts, United States, 01201
Contact: Cynthia Callahan, MD       ccallahan2@bhs1.org   
United States, North Dakota
Essentia Health, Fargo Not yet recruiting
Fargo, North Dakota, United States, 58103
Contact: Jaise Poulose, MD       jaise.poulose@essentiahealth.org   
United States, Pennsylvania
Geisinger Health System Not yet recruiting
Danville, Pennsylvania, United States, 17822
Contact: Uchenna Ofoma, MD       uofoma@geisinger.edu   
Sponsors and Collaborators
Mayo Clinic
Berkshire Medical Center, Pittsfield
Bridgeport Hospital
Detroit Medical Center
Essentia Health, Fargo
Geisinger Clinic
Marshfield Clinic Research Foundation
Memorial Hospital of Rhode Island
Mercy Hospital. Saint Louis
Ohio State University
University of North Carolina
UPMC at Hamot
Investigators
Study Director: Rahul Kashyap, MBBS Mayo Clinic
  More Information

No publications provided

Responsible Party: Nathan J. Smischney, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02508948     History of Changes
Other Study ID Numbers: 15-002328
Study First Received: July 21, 2015
Last Updated: July 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
airway management
critically ill
hemodynamic management
intubation
prospective study
risk factors

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 03, 2015