NCT04852263

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

April 9, 2021

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oxygen saturation

    It was regularly observed during procedure

    During procedure

Secondary Outcomes (1)

  • Time taken to successful intubation

    During procedure

Study Arms (2)

Group I

OTHER

Fiberoptic intubation was carried out without nasopharyngeal airway

Other: Group I

Group II (NPA group)

OTHER

Fiberoptic intubation was performed with a modified nasopharyngeal airway.

Other: Group II (NPA group)

Interventions

Group IOTHER

Oral fiberoptic intubation was carried out using lingual traction without nasopharyngeal airway.

Also known as: Oral fiberoptic intubation
Group I

Oral fiberoptic intubation was carried out using lingual traction plus modified nasopharyngeal airway.

Also known as: Oral fiberoptic intubation plus modified nasopharyngeal airway
Group II (NPA group)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with normal airway,
  • years,
  • ASA grade I - III with mallampati class I or II.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 21, 2021

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

March 1, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations