Airway ManagementNCT04769154
Adult Airway Management in the Intensive Care Units and Regular Floors
An observational study of Airway Management and Intensive Care Unit, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The goal of this prospective observational study is to assess investigate the incidence of first attempt success rate of endotracheal intubation. Secondary objectives included assessing the predictors of first attempt success rate and the incidence and predictors of adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management, Intensive Care Unit
- How many people
- 199 participants
- Where
- 1 siteLebanon
- Study dates
- 2 Mar 2021to 26 Sep 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring elective or emergent endotracheal intubation
Who may be able to join
- 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
Who cannot join
- Patients in the ED.
- Patients intubated by non-anesthesia providers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adult Airway Management in The Intensive Care Units and Regular Floors: A Prospective Observational Study in A Tertiary Care Center
The goal of this prospective observational study is to assess investigate the incidence of first attempt success rate of endotracheal intubation. Secondary objectives included assessing the predictors of first attempt success rate and the incidence and predictors of adverse events. 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.
Read the detailed description
Airway management is one of the pivotal roles of anesthesiologists that extends beyond the OR to include ICUs and regular hospital floors. Managing airways outside the OR is inherently complex and challenging. Numerous guidelines for non-OR airway management exist to assist practitioners. The American University of Beirut Medical Center (AUBMC), a tertiary care facility in a lower-to-middle-income country, experienced significant variation in practices concerning non-OR airway management, similar to other institutions. Nearly a decade ago, the quality, accreditation, and risk management department partnered with the Anesthesiology and Pain Management department to implement a care bundle for airway management outside the OR, excluding the Emergency Department (ED). This multidisciplinary approach prompted an assessment of our practices, aiming to compare our success and complication rates with the literature and international benchmarks.
This is a prospective observational study to evaluate the outcomes of endotracheal intubations for critically ill patients in ICUs and on regular floors. Data were prospectively collected by the anesthesia nurse assisting in the procedure or extracted from the electronic record as appropriate.
The sample size was calculated using the estimation of a simple proportion method (https://epitools.ausvet.com.au/oneproportion). Studies have shown a first attempt success rate of 75%. Based on these results, a sample size of 100 patients was calculated, based on an estimated proportion of 70%, a desired precision of estimate of 10%, a confidence level of 95%, and an estimated dropout rate of 20%. However, to improve the power of our study and to allow for subgroup analysis, we elected to enroll 200 patients. All statistical analyses were conducted using IBM-SPSS (version 29, Armonk NY, USA).
Descriptive analysis was performed for patients' demographics and the clinical characteristics of the study participants. Means and standard deviations were computed for continuous variables, and frequencies and percentages were calculated for categorical variables. Simple logistic regression was used to study the correlation between preoperative variables with the first attempt success rate. Also, simple logistic regression was used to study the association between preoperative variables, and the development of hypotension and hypoxemia during intubation. Variables with a P value < 0.25 were included in the multivariable logistic regression analysis. Multivariable logistic regression analysis was performed to identify the independent predictors of first attempt success rate, hypotension and hypoxemia during intubation, while adjusting for other preoperative variables. A P value < 0.05 was considered statistically significant. Multi-collinearity between covariates was assessed using Pearson's Correlation Coefficient. All models' fits were assessed using the Hosmer and Lemeshow test and using the C statistic, which is the area under the receiver operating characteristic curve.
- Conditions
- Airway Management, Intensive Care Unit
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of endotracheal intubation at first attempt
The success rate of endotracheal intubation at first attempt outside the OR
Measured: During endotracheal intubation
Secondary outcomes (7)
Adverse events (Hypoxemia)
Hypoxemia (SpO2 < 85%)
Measured: During the procedure
Adverse events (Hypotension)
Hypotension (SBP < 80 mmHg)
Measured: During the procedure
Adverse events (cardiac arrest)
Development of cardiac arrest
Measured: During the procedure
Total number of attempts
Total number of attempts
Measured: During the procedure
Time to successful intubation
Time to successful intubation in minutes
Measured: During the procedure
Equipment
Type of equipments used (direct laryngoscopy/video laryngoscopy/awake fiberoptic)
Measured: During the procedure
Medications
Type of medications used (Rocuronium, Midazolam, Propofol, vasoactive drugs)
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start2 Mar 2021
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marie Awad, American University of Beirut Medical Center
- Investigators
- Marie Aouad-Maroun, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769154
- Sponsor's protocol ID
- BIO-2020-0049
- Status last verified
- Aug 2024
- First submitted
- 23 Feb 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Airway Management in The Intensive Care Units and Regular Floors: A Prospective Observational Study in A Tertiary Care Center
- ClinicalTrials.gov ID
- NCT04769154
- Acronym / sponsor ID
- BIO-2020-0049
- Conditions
- Airway Management, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective observational study is to assess investigate the incidence of first attempt success rate of endotracheal intubation. Secondary objectives included assessing the predictors of first attempt success rate and the incidence and predictors of adverse events. 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.
Detailed description
Airway management is one of the pivotal roles of anesthesiologists that extends beyond the OR to include ICUs and regular hospital floors. Managing airways outside the OR is inherently complex and challenging. Numerous guidelines for non-OR airway management exist to assist practitioners. The American University of Beirut Medical Center (AUBMC), a tertiary care facility in a lower-to-middle-income country, experienced significant variation in practices concerning non-OR airway management, similar to other institutions. Nearly a decade ago, the quality, accreditation, and risk management department partnered with the Anesthesiology and Pain Management department to implement a care bundle for airway management outside the OR, excluding the Emergency Department (ED). This multidisciplinary approach prompted an assessment of our practices, aiming to compare our success and complication rates with the literature and international benchmarks.
This is a prospective observational study to evaluate the outcomes of endotracheal intubations for critically ill patients in ICUs and on regular floors. Data were prospectively collected by the anesthesia nurse assisting in the procedure or extracted from the electronic record as appropriate.
The sample size was calculated using the estimation of a simple proportion method (https://epitools.ausvet.com.au/oneproportion). Studies have shown a first attempt success rate of 75%. Based on these results, a sample size of 100 patients was calculated, based on an estimated proportion of 70%, a desired precision of estimate of 10%, a confidence level of 95%, and an estimated dropout rate of 20%. However, to improve the power of our study and to allow for subgroup analysis, we elected to enroll 200 patients. All statistical analyses were conducted using IBM-SPSS (version 29, Armonk NY, USA).
Descriptive analysis was performed for patients' demographics and the clinical characteristics of the study participants. Means and standard deviations were computed for continuous variables, and frequencies and percentages were calculated for categorical variables. Simple logistic regression was used to study the correlation between preoperative variables with the first attempt success rate. Also, simple logistic regression was used to study the association between preoperative variables, and the development of hypotension and hypoxemia during intubation. Variables with a P value < 0.25 were included in the multivariable logistic regression analysis. Multivariable logistic regression analysis was performed to identify the independent predictors of first attempt success rate, hypotension and hypoxemia during intubation, while adjusting for other preoperative variables. A P value < 0.05 was considered statistically significant. Multi-collinearity between covariates was assessed using Pearson's Correlation Coefficient. All models' fits were assessed using the Hosmer and Lemeshow test and using the C statistic, which is the area under the receiver operating characteristic curve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring elective or emergent endotracheal intubation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients in the ED.
- Patients intubated by non-anesthesia providers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The success rate of endotracheal intubation at first attempt
Time frame: During endotracheal intubation
The success rate of endotracheal intubation at first attempt outside the OR
7 secondary outcomes
Adverse events (Hypoxemia)
Time frame: During the procedure
Adverse events (Hypotension)
Time frame: During the procedure
Adverse events (cardiac arrest)
Time frame: During the procedure
Total number of attempts
Time frame: During the procedure
Time to successful intubation
Time frame: During the procedure
Equipment
Time frame: During the procedure
Medications
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Related trials for Airway Management
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Not yet recruitingPhase 2
A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Aouad-Maroun, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and Intensive Care Unit, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of endotracheal intubation at first attempt (time frame: During endotracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.