Intubated PatientsNGTNCT04414839
Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy
A study testing Digital Intubation (Two-finger) and Video Laryngoscopy in people with Intubated Patients, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Abstract Background: A number of patients referring to the emergency departments (EDs) due to airway obstruction or decreased level of consciousness require the establishment of a definite airway using intubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubated Patients
- What is being tested?
- Digital Intubation (Two-finger) and Video Laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2018to 15 May 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 year old patients that underwent rapid sequence intubation (RSI) and required NGT insertion
Who cannot join
- having skull base fracture symptoms
- coagulopathy and hemorrhagic disorders
- maxillofacial traumas leading to the deformity and disturbance in NGT insertion
- diseases and anomalies of the upper respiratory tract
- deviated nasal septum
- nostril stenosis
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- esophageal disorders (esophageal stricture, esophageal varices)
- a history of head and neck radiotherapy, and
- patients intubated in and transferred from other centers
- patients with more than two unsuccessful attempts at NGT insertion were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy Methods During Nasogastric Tube Insertion in Intubated Patients
Abstract Background: A number of patients referring to the emergency departments (EDs) due to airway obstruction or decreased level of consciousness require the establishment of a definite airway using intubation. On the other hand, performing Nasogastric tube (NGT) insertion is very challenging in anesthetized and intubated patients. And, a conclusive method has not yet been presented in this regard. Hence, the current study aimed at comparing Digital Intubation (two-finger) and Video Laryngoscopy methods during NGT insertion.
Materials and Methods: The present clinical trial was performed on 76 intubated patients that were randomly divided into two groups. Groups A and B underwent Video Laryngoscopy and Digital Intubation (two-finger) methods, respectively. Then, the success rate, the number of attempts to insert NGT, duration of insertion, hemodynamic parameters, and patients' satisfaction level were recorded and examined in this study.
- Conditions
- Intubated Patients
- Being tested
- Digital Intubation (Two-finger), Video Laryngoscopy
- Keywords
- Digital Laryngoscopy, Endotracheal Tube, Nasogastric Tube (NGT), Video Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Intubation (Two-finger)Device
In the NGT Digital Intubation group (group B), the second and third fingers were placed in the posterior pharynx and depressed the tongue downwards. The NGT was passed through the nose into the posterior pharynx with the fingers in the pharynx to reach the esophagus. The thumb was placed under the jaw and pushed it forward to pave the way for tube insertion.
Video LaryngoscopyDevice
In the NGT Video Laryngoscopy group (group A), first, the GlideScope blade was inserted under direct visualization via color monitor through the patient's mouth by employing jaw-thrust maneuver to preserve the cervical spine and by raising the tongue to obtain better visualization of the larynx space. Then, NGT was inserted through the selected nostril, advanced through the esophagus under direct vision to meet the measured length, and fixed after confirmation.
| Study group | Role | What they receive |
|---|---|---|
| Digital Intubation (Two-finger) | Active comparator | Not described Receives: Device: Digital Intubation (Two-finger) |
| Video Laryngoscopy | Active comparator | Not described Receives: Device: Video Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
being successfully inserted into the stomach
Measured: Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)
Secondary outcomes (1)
Insertion duration
Measuring how long will it last to insert successfully an NG tube into the stomach
Measured: Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2018
- Primary completion20 Mar 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubated PatientsStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414839
- Sponsor's protocol ID
- 397585
- Acronym
- NGT
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: if requested, it will be shared formally by email to the journal office.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy Methods During Nasogastric Tube Insertion in Intubated Patients
- ClinicalTrials.gov ID
- NCT04414839
- Acronym / sponsor ID
- NGT / 397585
- Conditions
- Intubated Patients
- Keywords
- Digital Laryngoscopy, Endotracheal Tube, Nasogastric Tube (NGT), Video Laryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 4 Jun 2020 (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.
Abstract Background: A number of patients referring to the emergency departments (EDs) due to airway obstruction or decreased level of consciousness require the establishment of a definite airway using intubation. On the other hand, performing Nasogastric tube (NGT) insertion is very challenging in anesthetized and intubated patients. And, a conclusive method has not yet been presented in this regard. Hence, the current study aimed at comparing Digital Intubation (two-finger) and Video Laryngoscopy methods during NGT insertion.
Materials and Methods: The present clinical trial was performed on 76 intubated patients that were randomly divided into two groups. Groups A and B underwent Video Laryngoscopy and Digital Intubation (two-finger) methods, respectively. Then, the success rate, the number of attempts to insert NGT, duration of insertion, hemodynamic parameters, and patients' satisfaction level were recorded and examined in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Intubation (Two-finger) | Active comparator | Device: Digital Intubation (Two-finger) |
| Video Laryngoscopy | Active comparator | Device: Video Laryngoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 year old patients that underwent rapid sequence intubation (RSI) and required NGT insertion
Key exclusion criteria (10 listed)
- having skull base fracture symptoms
- coagulopathy and hemorrhagic disorders
- maxillofacial traumas leading to the deformity and disturbance in NGT insertion
- diseases and anomalies of the upper respiratory tract
- 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 |
|---|---|---|
| Digital Intubation (Two-finger)In the NGT Digital Intubation group (group B), the second and third fingers were placed in the posterior pharynx and depressed the tongue downwards. The NGT was passed through the nose into the posterior pharynx with the fingers in the pharynx to reach the esophagus. The thumb was placed under the jaw and pushed it forward to pave the way for tube insertion. | Device | Digital Intubation (Two-finger) |
| Video LaryngoscopyIn the NGT Video Laryngoscopy group (group A), first, the GlideScope blade was inserted under direct visualization via color monitor through the patient's mouth by employing jaw-thrust maneuver to preserve the cervical spine and by raising the tongue to obtain better visualization of the larynx space. Then, NGT was inserted through the selected nostril, advanced through the esophagus under direct vision to meet the measured length, and fixed after confirmation. | Device | Video Laryngoscopy |
Primary outcome
Success rate
Time frame: Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)
being successfully inserted into the stomach
1 secondary outcome
Insertion duration
Time frame: Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)
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 4 Jun 2020.
- Individual participant dataSharing planned: Undecided. if requested, it will be shared formally by email to the journal office.
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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 Digital Intubation (Two-finger) and Video Laryngoscopy in people with Intubated Patients, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 10 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 4 Jun 2020. 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 Iran. 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?
Success rate (time frame: Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)). 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 4 Jun 2020.