Adult Airway Management in the Intensive Care Units and Regular Floors

Intensive Care Unit Clinical Trial

Official title:

Adult Airway Management in the Intensive Care Units and Regular Floors: A Prospective Observational Study in a Tertiary Care Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769154
• Other study ID #: BIO-2020-0049
• Status: Completed
• Start date: March 2, 2021
• Est. completion date: September 26, 2023

Study information

• Verified date: June 2024
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this descriptive observational study is to assess the success rate of endotracheal intubation at first attempt outside the operating room with direct laryngoscopy or with the use of an assisting device and identify adverse events; mainly hypoxemia (SpO2 < 85%), hypotension (SBP < 80 mmHg), and cardiac arrest in patients requiring elective or emergent endotracheal intubation. The main question it aims to answer is whether endotracheal intubation outside the OR at AUBMC has higher success rates and lower complication rates as compared to the literature. Participants will be evaluated according to the inclusion criteria and data extraction will be performed from the electronic health record (EHR). Researchers will compare success and complication rates with previous literature and international benchmarks.

Description:

Compared with airway management inside the OR, airway management outside the OR is associated with a higher rate of complications. This higher rate of complications outside the OR shows that even despite multiple guidelines for the management of difficult airway, there is still a lot of room for improvement.

This descriptive observational study will be conducted at the American University of Beirut Medical Center (AUBMC) on regular floors and in the ICU, on patients requiring elective or emergent endotracheal intubation.

The primary outcome is to assess the success rate of endotracheal intubation at first attempt outside the OR with direct laryngoscopy or the use of an assisting device. Secondary outcomes will identify adverse events mainly hypoxemia, hypotension, and cardiac arrest.

The hypothesis is that endotracheal intubation outside the OR at AUBMC has higher success rates and lower complication rates as compared to the literature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing elective or emergent intubation on regular floors or ICU or COVID patients.

• Patients above 18 years of age.

• Intubation done by an anesthesia provider with at least 2 years of experience

Exclusion Criteria:

• Patients in the ED.

• Patients intubated by non-anesthesia providers.

Related Conditions & MeSH terms

• Airway Management
• Intensive Care Unit

Locations

Country	Name	City	State
Lebanon	AUBMC	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of endotracheal intubation at first attempt	The success rate of endotracheal intubation at first attempt outside the OR with direct laryngoscopy or the use of an assisting device	During endotracheal intubation
Secondary	Adverse events (Hypoxemia)	Hypoxemia (SpO2 < 85%)	During the procedure
Secondary	Adverse events (Hypotension)	Hypotension (SBP < 80 mmHg)	During the procedure
Secondary	Adverse events (cardiac arrest)	Development of cardiac arrest	During the procedure