Intubation; Difficult or FailedNCT06449924
An Endotracheal Tube Inserted to the Level of the Hypopharynx
An observational study of Intubation; Difficult or Failed and Pediatric ALL, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The goal of this observational study is to assess the incidence of successful ventilation using an ETT inserted orally above the vocal cords in pediatric patients undergoing surgeries. Read more about this study
- Who is it for?
- Ages 1 month to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Pediatric ALL, Ventilator Lung
- What is being tested?
- Endotracheal tube
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 1 siteLebanon
- Study dates
- 21 Jun 2024to 22 Aug 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 1 month to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants and children who are > 1 month and ≤ 6 years old undergoing elective surgeries at the American University of Beirut Medical Center (AUBMC).
Who may be able to join
- Age > 1 month and ≤ 6 years
- Legal guardian/representative willing to sign consent
Who cannot join
- BMI > 30 kg/m2
- Patient with a risk of aspiration of history of GERD
- Inability or unwillingness of research participant's legal guardian/ representative to give consent
- Need for emergency surgery
- ASA Ⅲ-Ⅳ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Endotracheal Tube Inserted to the Level of the Hypopharynx is an Easy, Safe, and Effective Technique for Ventilation of Pediatric Patients: A Prospective Observational Study
The goal of this observational study is to assess the incidence of successful ventilation using an ETT inserted orally above the vocal cords in pediatric patients undergoing surgeries. The main question it aims to answer are:
Is the use of an endotracheal tube (ETT), positioned in the hypopharynx with its tip placed just above the vocal cords an easy, safe and effective way for the ventilation of pediatric patients who are undergoing surgery under general anesthesia via orotracheal intubation?
The procedures to be performed in this study are standard of care. They are also used by pediatric anesthesiologists in the oral intubation of pediatric patients suffering from tumor or abscess.
Read the detailed description
Background: Tracheal intubation can be challenging in the pediatric age group. The difficult airway algorithm is followed starting with ventilation via a facemask. In cases of difficulties in intubation and ventilation, and especially in neonates and small infants, oxygen desaturation can happen very quickly and can be life threatening. The endotracheal tube (ETT), which is readily available and bypasses the tongue of the patient, can provide a safe and efficient ventilation.
Specific Aim (s): In our study, we aim at assessing the incidence of successful ventilation using an ETT inserted orally above the vocal cords in pediatric patients undergoing surgeries. Secondary objectives include assessing the incidence of severe hypoxemia (SpO2 < 85%) along with other adverse events, such as bradycardia, stomach insufflation, and laryngospasm
Methods: This prospective, observational study will include 85 infants and small children aged > 1 month and ≤ 6 years old, undergoing elective surgery under general anesthesia with orotracheal intubation. The effectiveness and safety of hypopharyngeal ETT ventilation performed by clinical anesthesia (CA) residents will be evaluated. The primary objective of this study is to assess the efficacy of this technique in providing successful ventilation evidenced by visible chest rise, the presence of a sustained end-tidal capnography (EtCO2) waveform, stable oxygen saturation (SpO2) values, and an adequate expired tidal volume. Secondary outcomes include the incidence of severe hypoxemia (SpO2 < 85%), bradycardia, stomach insufflation, and laryngospasm.
Significance: This ETT technique is simple to implement and use, requiring no special training or equipment. This technique can save time by ensuring patients' oxygenation and ventilation.
- Being tested
- Endotracheal tube
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tubeDevice
Endotracheal Tube Inserted to the Level of the Hypopharynx
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful ventilation
Successful ventilation which is evaluated according to the following criteria:
Delivery of adequate expired tidal volume, a stable value of SpO2, and at least eight end tidal CO2 waveforms.
Measured: During intubation
Secondary outcomes (2)
Incidence of severe hypoxemia
Incidence of severe hypoxemia (SPO2 less than 85%)
Measured: During intubation
Incidence of adverse events
Incidence of adverse events such as bradycardia, stomach insufflation, and laryngospasm
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start21 Jun 2024
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Kaddoum, American University of Beirut Medical Center
- Investigators
- Roland Kaddoum, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449924
- Sponsor's protocol ID
- BIO-2024-0114
- Status last verified
- May 2026
- First submitted
- 4 Jun 2024
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Senbruna BO, Khalili AF, Siddik-Sayyid SM, Krayem RM, HajAli TH, Itani SM, Maroun PJ, Bou Ali AW, Aouad MT, Kaddoum RN. An endotracheal tube inserted to the level of the hypopharynx is an easy, safe, and effective technique for ventilation of pediatric patients: A prospective observational study. J Clin Anesth. 2026 Aug 22;114:112305. doi: 10.1016/j.jclinane.2026.112305. Online ahead of print.
PubMed 42632161
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Endotracheal Tube Inserted to the Level of the Hypopharynx is an Easy, Safe, and Effective Technique for Ventilation of Pediatric Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06449924
- Acronym / sponsor ID
- BIO-2024-0114
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 10 Jun 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.
The goal of this observational study is to assess the incidence of successful ventilation using an ETT inserted orally above the vocal cords in pediatric patients undergoing surgeries. The main question it aims to answer are:
Is the use of an endotracheal tube (ETT), positioned in the hypopharynx with its tip placed just above the vocal cords an easy, safe and effective way for the ventilation of pediatric patients who are undergoing surgery under general anesthesia via orotracheal intubation?
The procedures to be performed in this study are standard of care. They are also used by pediatric anesthesiologists in the oral intubation of pediatric patients suffering from tumor or abscess.
Detailed description
Background: Tracheal intubation can be challenging in the pediatric age group. The difficult airway algorithm is followed starting with ventilation via a facemask. In cases of difficulties in intubation and ventilation, and especially in neonates and small infants, oxygen desaturation can happen very quickly and can be life threatening. The endotracheal tube (ETT), which is readily available and bypasses the tongue of the patient, can provide a safe and efficient ventilation.
Specific Aim (s): In our study, we aim at assessing the incidence of successful ventilation using an ETT inserted orally above the vocal cords in pediatric patients undergoing surgeries. Secondary objectives include assessing the incidence of severe hypoxemia (SpO2 < 85%) along with other adverse events, such as bradycardia, stomach insufflation, and laryngospasm
Methods: This prospective, observational study will include 85 infants and small children aged > 1 month and ≤ 6 years old, undergoing elective surgery under general anesthesia with orotracheal intubation. The effectiveness and safety of hypopharyngeal ETT ventilation performed by clinical anesthesia (CA) residents will be evaluated. The primary objective of this study is to assess the efficacy of this technique in providing successful ventilation evidenced by visible chest rise, the presence of a sustained end-tidal capnography (EtCO2) waveform, stable oxygen saturation (SpO2) values, and an adequate expired tidal volume. Secondary outcomes include the incidence of severe hypoxemia (SpO2 < 85%), bradycardia, stomach insufflation, and laryngospasm.
Significance: This ETT technique is simple to implement and use, requiring no special training or equipment. This technique can save time by ensuring patients' oxygenation and ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants and children who are > 1 month and ≤ 6 years old undergoing elective surgeries at the American University of Beirut Medical Center (AUBMC).
Key inclusion criteria (2 listed)
- Age > 1 month and ≤ 6 years
- Legal guardian/representative willing to sign consent
Key exclusion criteria (5 listed)
- BMI > 30 kg/m2
- Patient with a risk of aspiration of history of GERD
- Inability or unwillingness of research participant's legal guardian/ representative to give consent
- Need for emergency surgery
- ASA Ⅲ-Ⅳ
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 |
|---|---|---|
| Endotracheal tubeEndotracheal Tube Inserted to the Level of the Hypopharynx | Device | – |
Primary outcome
Successful ventilation
Time frame: During intubation
Successful ventilation which is evaluated according to the following criteria: Delivery of adequate expired tidal volume, a stable value of SpO2, and at least eight end tidal CO2 waveforms.
2 secondary outcomes
Incidence of severe hypoxemia
Time frame: During intubation
Incidence of adverse events
Time frame: During intubation
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 14 May 2026.
- Derived from this study: PubMed 42632161Senbruna BO, Khalili AF, Siddik-Sayyid SM, Krayem RM, HajAli TH, Itani SM, Maroun PJ, Bou Ali AW, Aouad MT, Kaddoum RN. An endotracheal tube inserted to the level of the hypopharynx is an easy, safe, and effective technique for ventilation of pediatric patients: A prospective observational study. J Clin Anesth. 2026 Aug 22;114:112305. doi: 10.1016/j.jclinane.2026.112305. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Roland Kaddoum, 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 Intubation; Difficult or Failed and Pediatric ALL, 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 2 inclusion and 5 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 14 May 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 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?
Successful ventilation (time frame: During intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449924, which also lists 1 linked publication.
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 14 May 2026.