SurgeryNCT04852263
Shortened Uncuffed Endotracheal Tube as a Nasopharyngeal Airway in Training in Fiberoptic Intubation
A study testing Group I and Group II (NPA group) in people with Surgery, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Background: Fiberoptic intubation is an effective technique for establishing airway access in patients with critical airways. Objective: It was hypothesized that the learning of oral fiberoptic intubation by the anesthesia resident trainee is easier and safe using modified nasopharyngeal airway. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Surgery
- What is being tested?
- Group I and Group II (NPA group)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2019to 1 Mar 2021
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with normal airway,
- 20-60 years,
- ASA grade I - III with mallampati class I or II.
Who cannot join
- Patients who refused to undergo the procedure,
- Presence of an absolute contraindication to nasal intubation like head trauma, a nasal mass, and deviated nasal septum.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Prince Sattam bin Abdulaziz University
Al Kharj, Riyadh Region, 11942
About this study
Official title: Using a Shortened Uncuffed Endotracheal Tube as a Nasopharyngeal Airway: a Useful Adjunct During Fiberoptic Intubation Training Among Anesthesia Residents
Background: Fiberoptic intubation is an effective technique for establishing airway access in patients with critical airways.
Objective: It was hypothesized that the learning of oral fiberoptic intubation by the anesthesia resident trainee is easier and safe using modified nasopharyngeal airway.
Methodology: This prospective randomized study was done on 62 adult patients with normal airway scheduled for elective oral fiberoptic intubation, their age 20 -60 years, 56 males and 6 females, American Society of Anesthesiologists I-III class. After institute ethical committee clearance and written informed consent, patients were randomly divided into two groups of 31 each; Group I: oral fiberoptic intubation was carried out using lingual traction. In group II, FOI was carried out using lingual traction plus a shortened uncuffed nasal endotracheal tube (modified nasopharyngeal airway). Time taken to successful tracheal intubation and other technical parameters were recorded. Heart rate, mean arterial blood pressure, oxygen saturation, end-tidal carbon dioxide tension, and any associated complications were also recorded.
Read the detailed description
Patients with normal airway, 20 - 60 years, ASA grade I-III with mallampati class I or II were scheduled for elective oral FOI. Patients who refused to undergo the procedure, presence of an absolute contraindication to nasal intubation like head trauma, a nasal mass, and deviated nasal septum were excluded from the study.
Patients were randomly divided into two equal groups; Group I: FOI was carried out without NPA, and Group II: FOI was performed using NPA (NPA group). Lingual traction was used in both groups. Patients were optimized for surgery and fasting for 8 hours. While the patients in the preoperative holding area, they were premedicated with glycopyrrolate 0.2 mg intravenously 30 min prior to the procedure. At the same time, patients have been treated with xylometazoline 0.1% nasal drops in both nostrils followed by lignocaine jelly 2%.
All staff in the pre, intra, and postoperative area are licensed with ACLS according to the standard and guidelines of patient safety. The patient file and vital signs will be monitored during the stay in the holding area to discover any abnormalities. And each patient will sign a written consent form after explaining and informing about the procedure of the study. Vital signs (pulse, blood pressure, respiratory rate, and body temperature) and oxygen saturation will be checked before receiving any medication and frequently every 5 minutes till the end of the procedure to detect early concerns (hemodynamics instability, bleeding, neurocognitive dysfunction, and failed technique) The procedure was stopped if any patient feels abnormality or observed by a physician.
ENT consultant must be informed before the procedure to be around. Consultant Anesthesia will be closely included during the procedure for maintaining the accurate and optimum procedure.
In the operating room, patients were connected to standard monitors including pulse oximetry, ECG, non-invasive blood pressure, and temperature monitoring prior to administering premedication drugs. Then, 2 mg of midazolam and 50 μg fentanyl were injected intravenously 3 min prior to the procedure. In a group, II (NPA group), when the patient sedated with midazolam and fentanyl, a well-lubricated uncuffed tube (Portex®) 7.0 for male and 6.5 for female) was inserted nasally and advanced until the tip stands just above the opening of the larynx and then connected to a source of oxygen. After a period of 2-3 min of preoxygenation, the patient was anesthetized with total intravenous anesthesia (TIVA) using propofol and remifentanil infusion. The anesthesia resident trainee was asked to use a fiberoptic bronchoscope (Karl Storz® Intubation fiberscope 11301 BN1) to pass it through a cuffed endotracheal tube (ETT), visualize the vocal cords, pass through the glottic aperture and then pass the ETT over the fiberoptic bronchoscope. The correct ETT placement was confirmed by visualization of the carina and tracheal rings and bilateral equal air entry. The same scenario was done by the resident trainee in group I but without using the NPA.
The time of fiberscope insertion and intubation and the number of attempts were recorded. Hemodynamic and respiratory changes (HR, MAP, SpO2, and ETCo2) were recorded at 3 points; at the baseline before induction of anesthesia, during insertion of the scope (two minutes after induction of anesthesia), and after FOI (two minutes after securing ETT). Any adverse events were also recorded as sore throat, PONV, dental trauma,...etc. If necessary, facilitating techniques like jaw thrusts were used.
- Conditions
- Surgery
- Being tested
- Group I, Group II (NPA group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group IOther
Also called Oral fiberoptic intubation
Oral fiberoptic intubation was carried out using lingual traction without nasopharyngeal airway.
Group II (NPA group)Other
Also called Oral fiberoptic intubation plus modified nasopharyngeal airway
Oral fiberoptic intubation was carried out using lingual traction plus modified nasopharyngeal airway.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Other | Fiberoptic intubation was carried out without nasopharyngeal airway Receives: Other: Group I |
| Group II (NPA group) | Other | Fiberoptic intubation was performed with a modified nasopharyngeal airway. Receives: Other: Group II (NPA group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
It was regularly observed during procedure
Measured: During procedure
Secondary outcomes (1)
Time taken to successful intubation
It was recorded from starting to completion of fibroptic intubation
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abodonya, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852263
- Sponsor's protocol ID
- REC-HSD-67-2021
- Status last verified
- Aug 2021
- First submitted
- 9 Apr 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Shortened Uncuffed Endotracheal Tube as a Nasopharyngeal Airway: a Useful Adjunct During Fiberoptic Intubation Training Among Anesthesia Residents
- ClinicalTrials.gov ID
- NCT04852263
- Acronym / sponsor ID
- REC-HSD-67-2021
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 21 Apr 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.
Background: Fiberoptic intubation is an effective technique for establishing airway access in patients with critical airways.
Objective: It was hypothesized that the learning of oral fiberoptic intubation by the anesthesia resident trainee is easier and safe using modified nasopharyngeal airway.
Methodology: This prospective randomized study was done on 62 adult patients with normal airway scheduled for elective oral fiberoptic intubation, their age 20 -60 years, 56 males and 6 females, American Society of Anesthesiologists I-III class. After institute ethical committee clearance and written informed consent, patients were randomly divided into two groups of 31 each; Group I: oral fiberoptic intubation was carried out using lingual traction. In group II, FOI was carried out using lingual traction plus a shortened uncuffed nasal endotracheal tube (modified nasopharyngeal airway). Time taken to successful tracheal intubation and other technical parameters were recorded. Heart rate, mean arterial blood pressure, oxygen saturation, end-tidal carbon dioxide tension, and any associated complications were also recorded.
Detailed description
Patients with normal airway, 20 - 60 years, ASA grade I-III with mallampati class I or II were scheduled for elective oral FOI. Patients who refused to undergo the procedure, presence of an absolute contraindication to nasal intubation like head trauma, a nasal mass, and deviated nasal septum were excluded from the study.
Patients were randomly divided into two equal groups; Group I: FOI was carried out without NPA, and Group II: FOI was performed using NPA (NPA group). Lingual traction was used in both groups. Patients were optimized for surgery and fasting for 8 hours. While the patients in the preoperative holding area, they were premedicated with glycopyrrolate 0.2 mg intravenously 30 min prior to the procedure. At the same time, patients have been treated with xylometazoline 0.1% nasal drops in both nostrils followed by lignocaine jelly 2%.
All staff in the pre, intra, and postoperative area are licensed with ACLS according to the standard and guidelines of patient safety. The patient file and vital signs will be monitored during the stay in the holding area to discover any abnormalities. And each patient will sign a written consent form after explaining and informing about the procedure of the study. Vital signs (pulse, blood pressure, respiratory rate, and body temperature) and oxygen saturation will be checked before receiving any medication and frequently every 5 minutes till the end of the procedure to detect early concerns (hemodynamics instability, bleeding, neurocognitive dysfunction, and failed technique) The procedure was stopped if any patient feels abnormality or observed by a physician.
ENT consultant must be informed before the procedure to be around. Consultant Anesthesia will be closely included during the procedure for maintaining the accurate and optimum procedure.
In the operating room, patients were connected to standard monitors including pulse oximetry, ECG, non-invasive blood pressure, and temperature monitoring prior to administering premedication drugs. Then, 2 mg of midazolam and 50 μg fentanyl were injected intravenously 3 min prior to the procedure. In a group, II (NPA group), when the patient sedated with midazolam and fentanyl, a well-lubricated uncuffed tube (Portex®) 7.0 for male and 6.5 for female) was inserted nasally and advanced until the tip stands just above the opening of the larynx and then connected to a source of oxygen. After a period of 2-3 min of preoxygenation, the patient was anesthetized with total intravenous anesthesia (TIVA) using propofol and remifentanil infusion. The anesthesia resident trainee was asked to use a fiberoptic bronchoscope (Karl Storz® Intubation fiberscope 11301 BN1) to pass it through a cuffed endotracheal tube (ETT), visualize the vocal cords, pass through the glottic aperture and then pass the ETT over the fiberoptic bronchoscope. The correct ETT placement was confirmed by visualization of the carina and tracheal rings and bilateral equal air entry. The same scenario was done by the resident trainee in group I but without using the NPA.
The time of fiberscope insertion and intubation and the number of attempts were recorded. Hemodynamic and respiratory changes (HR, MAP, SpO2, and ETCo2) were recorded at 3 points; at the baseline before induction of anesthesia, during insertion of the scope (two minutes after induction of anesthesia), and after FOI (two minutes after securing ETT). Any adverse events were also recorded as sore throat, PONV, dental trauma,...etc. If necessary, facilitating techniques like jaw thrusts were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Other | Other: Group IFiberoptic intubation was carried out without nasopharyngeal airway |
| Group II (NPA group) | Other | Other: Group II (NPA group)Fiberoptic intubation was performed with a modified nasopharyngeal airway. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with normal airway,
- 20-60 years,
- ASA grade I - III with mallampati class I or II.
Key exclusion criteria (2 listed)
- Patients who refused to undergo the procedure,
- Presence of an absolute contraindication to nasal intubation like head trauma, a nasal mass, and deviated nasal septum.
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 |
|---|---|---|
| Group IAlso: Oral fiberoptic intubationOral fiberoptic intubation was carried out using lingual traction without nasopharyngeal airway. | Other | Group I |
| Group II (NPA group)Also: Oral fiberoptic intubation plus modified nasopharyngeal airwayOral fiberoptic intubation was carried out using lingual traction plus modified nasopharyngeal airway. | Other | Group II (NPA group) |
Primary outcome
Oxygen saturation
Time frame: During procedure
It was regularly observed during procedure
1 secondary outcome
Time taken to successful intubation
Time frame: During 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 27 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Group I and Group II (NPA group) in people with Surgery, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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 27 Aug 2021. 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 Saudi Arabia. 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?
Oxygen saturation (time frame: During procedure). 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 27 Aug 2021.