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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Saudi Arabia

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 groups in NCT04852263
Study groupRoleWhat they receive
Group IOtherFiberoptic intubation was carried out without nasopharyngeal airway
Receives: Other: Group I
Group II (NPA group)OtherFiberoptic 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.

  1. Oxygen saturation

    It was regularly observed during procedure

    Measured: During procedure

Secondary outcomes (1)
  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.

  1. First posted21 Apr 2021
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2020
  4. Study completion1 Mar 2021

Resources

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)
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

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.

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