ObesityBARINTUBENCT06592313
Difficult Airway in the Bariatric Patient: The BARINTUBE Cohort Study
An observational study of Obesity and Bariatric Surgery Candidate, run by : Manuel Alberto Guerrero Gutierrez at 1 site in Mexico.
Trial summary
Background: Difficult airway in bariatric patients presents significant challenges during anesthesia, impacting patient safety and surgical outcomes. This study aims to estimate the incidence of difficult airway in bariatric patients undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- What is being tested?
- Intubation
- Type of treatment
- Surgery or procedure
- How many people
- 1,290 participants
- Where
- 1 siteMexico
- Study dates
- 15 Oct 2024to 20 Dec 2025
- 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 with a body mass index greater than or equal to 30 kg/m2 scheduled for bariatric surgery.
Who may be able to join
- Patients over 18 years of age
- Patients of both genders
- Patients diagnosed with BMI greater than or equal to 30 kg/m2
- Patients who will undergo bariatric surgery
- Patients who require intubation for intraoperative ariway management
Who cannot join
- Patients who withdraw their consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Medico Bariatrico
Tijuana, Estado de Baja California, 22046
About this study
Background: Difficult airway in bariatric patients presents significant challenges during anesthesia, impacting patient safety and surgical outcomes. This study aims to estimate the incidence of difficult airway in bariatric patients undergoing surgery.
Materials and Methods: This prospective observational cohort study will be conducted in a single center. Patients over 18 years with a BMI ≥ 30 kg/m2 undergoing bariatric surgery and requiring intubation will be included. Data will be collected on patient demographics, clinical characteristics, and intubation outcomes. The primary outcome is the occurrence of difficult airway, defined by specific criteria including intubation difficulty and the need for alternative airway management techniques. Secondary outcomes include complications related to airway management and overall surgical outcomes. A total of 1290 patients will be included in the study to estimate the incidence of difficult airway within a confidence of 3%.
Conclusions: Difficult airway management in bariatric patients is relatively common and is influenced by specific patient factors. The findings of this study will mainly allow the estimation of difficult airway incidence in patients with bariatric surgery under the new clinical definitions.
- Conditions
- Obesity, Bariatric Surgery Candidate
- Being tested
- Intubation
- Keywords
- bariatric surgery, difficult airway, videolaringoscopy, intubation, airway managment, obesity and anesthesia, preoperative care
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationProcedure or surgery
Aiway management procedure involving the Insertion of an orotracheal cannula through the oropharynx.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing bariatric surgery | Adults with an indication for bariatric surgery who have been schedule for a bariatric surgery procedure. Receives: Procedure: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of difficult airway
Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of difficult airway (anticipated or unanticipated difficulty or failure is experienced by a physician trained in anesthesia care, including but not limited to one or more of the following: facemask ventilation, laryngoscopy, ventilation using a supraglottic airway, tracheal intubation, extubation, or invasive airway).
Measured: Day 1
Secondary outcomes (5)
Incidence of severe hypoxia
Cumulative incidence (expressed as percentage) of severe hypoxia, defined as a peripheral blood oxygen saturation (SpO2) lower than 80% during advanced airway management.
Measured: Day 1
Incidence of cardiovascular collapse
Cumulative incidence (expressed as percentage) of cardiovascular collapse, defined as any of the following events within 30 minutes from induction to surgical incision:
- Systolic blood pressure lower than 65 mmHg.
- Dyastolic blood pressure ower than 90 mmHg for more than 15 minutes
- Unplanned need for vasopressors or fluid loading greater than; 15 ml/kg to maintain target blood pressure.
Measured: Day 1
Incidence of minor adverse events
Cumulative incidence (expressed as percentage) of minor adverse events, including:
- Moderate hypoxia (SpO2 lower than 93%),
- Airway injury,
- Clinically relevant bleeding,
- Oral aspiration of gastric contents,
- Dental injury,
- Lip injury.
Measured: Day 1
Incidence of Difficult Facemask Ventilation
Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of Difficult Facemask Ventilation (It is not possible to provide adequate ventilation, because of one or more of the following problems: inadequate mask seal, excessive gas leak, or excessive resistance to the ingress or egress of gas.). For operationalization, successful face mask ventilation with 2 hands will be consigned as the reference (No difficult face mask ventilation), whereas face mask ventilation attempts with 4 or 6 hands will be considered as the presence of difficult face mask ventilation.
Measured: Day 1
Incidence of Difficult or Failed Tracheal Intubation
Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of Difficult or Failed Tracheal Intubation (Tracheal intubation requires multiple attempts or tracheal intubation fails after multiple attempts.). For operationalization, more than 1 attempt will be considered as Difficult or Failed Tracheal Intubation.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2024
- Primary completion16 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 1,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- : Manuel Alberto Guerrero Gutierrez
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, : Manuel Alberto Guerrero Gutierrez, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592313
- Sponsor's protocol ID
- 1667/17-05-2024
- Acronym
- BARINTUBE
- Status last verified
- Jan 2026
- First submitted
- 9 Sep 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data will be deposited and made available through an open acess data repository (i.e., Harvard Dataverse). Any potentially sensitive patient-identifying data will either not be released or will undergo minimization and aggregation/abstraction procedures to reduce participant identification risk. Informed consent forms will indicate that a minimal risk of re-identification cannot be excluded despite all these participant data protection methods,in compliance with current IPD sharing recommendations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difficult Airway in the Bariatric Patient: The BARINTUBE Cohort Study
- ClinicalTrials.gov ID
- NCT06592313
- Acronym / sponsor ID
- BARINTUBE / 1667/17-05-2024
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- bariatric surgery, difficult airway, videolaringoscopy, intubation, airway managment, obesity and anesthesia, preoperative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,290 participants (actual)
- Lead sponsor
- : Manuel Alberto Guerrero GutierrezOther government
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 19 Sep 2024 (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.
Background: Difficult airway in bariatric patients presents significant challenges during anesthesia, impacting patient safety and surgical outcomes. This study aims to estimate the incidence of difficult airway in bariatric patients undergoing surgery.
Materials and Methods: This prospective observational cohort study will be conducted in a single center. Patients over 18 years with a BMI ≥ 30 kg/m2 undergoing bariatric surgery and requiring intubation will be included. Data will be collected on patient demographics, clinical characteristics, and intubation outcomes. The primary outcome is the occurrence of difficult airway, defined by specific criteria including intubation difficulty and the need for alternative airway management techniques. Secondary outcomes include complications related to airway management and overall surgical outcomes. A total of 1290 patients will be included in the study to estimate the incidence of difficult airway within a confidence of 3%.
Conclusions: Difficult airway management in bariatric patients is relatively common and is influenced by specific patient factors. The findings of this study will mainly allow the estimation of difficult airway incidence in patients with bariatric surgery under the new clinical definitions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing bariatric surgery | – | Procedure: IntubationAdults with an indication for bariatric surgery who have been schedule for a bariatric surgery procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a body mass index greater than or equal to 30 kg/m2 scheduled for bariatric surgery.
Key inclusion criteria (5 listed)
- Patients over 18 years of age
- Patients of both genders
- Patients diagnosed with BMI greater than or equal to 30 kg/m2
- Patients who will undergo bariatric surgery
- Patients who require intubation for intraoperative ariway management
Key exclusion criteria (1 listed)
- Patients who withdraw their consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntubationAiway management procedure involving the Insertion of an orotracheal cannula through the oropharynx. | Procedure or surgery | Patients undergoing bariatric surgery |
Primary outcome
Incidence of difficult airway
Time frame: Day 1
Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of difficult airway (anticipated or unanticipated difficulty or failure is experienced by a physician trained in anesthesia care, including but not limited to one or more of the following: facemask ventilation, laryngoscopy, ventilation using a supraglottic airway, tracheal intubation, extubation, or invasive airway).
5 secondary outcomes
Incidence of severe hypoxia
Time frame: Day 1
Incidence of cardiovascular collapse
Time frame: Day 1
Incidence of minor adverse events
Time frame: Day 1
Incidence of Difficult Facemask Ventilation
Time frame: Day 1
Incidence of Difficult or Failed Tracheal Intubation
Time frame: Day 1
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 22 Jan 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data will be deposited and made available through an open acess data repository (i.e., Harvard Dataverse). Any potentially sensitive patient-identifying data will either not be released or will undergo minimization and aggregation/abstraction procedures to reduce participant identification risk. Informed consent forms will indicate that a minimal risk of re-identification cannot be excluded despite all these participant data protection methods,in compliance with current IPD sharing recommendations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity and Bariatric Surgery Candidate, run by : Manuel Alberto Guerrero Gutierrez at 1 site in Mexico.
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 5 inclusion and 1 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 22 Jan 2026. 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 Mexico. 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?
Incidence of difficult airway (time frame: Day 1). 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 22 Jan 2026.