NCT05399147

Brief Summary

the aim of this work is to study how this technique will make nasal fiberoptic intubation easier and faster than the usual classic technique

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

March 19, 2022

Last Update Submit

October 12, 2022

Conditions

Difficult Intubation

Outcome Measures

Primary Outcomes (1)

  • time 1

    time 1 = time from start from start of introducing the bronchoscope till viewing the vocal cord measured in seconds.

    baseline

Secondary Outcomes (1)

  • other measures

    baseline

Study Arms (2)

classic group (CL group)

OTHER

20 patients will be enrolled to be intubated using the classic usual technique

Other: fiberoptic intubation classic technique

tube 1st group (TF group)

OTHER

20 patients will be enrolled to be intubated using the tube 1st technique

Other: fiberoptic intubation tube 1st technique

Interventions

fiberoptic intubation classic techniqueOTHER

classic fiberoptic intubation

classic group (CL group)
fiberoptic intubation tube 1st techniqueOTHER

tube 1st technique

tube 1st group (TF group)

Eligibility Criteria

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

You may qualify if:

  • Age between 20 and 60 years,
  • ASA Class I\& II,
  • Maxillofacial surgeries ex: mandibular surgery, orthognathic surgery and dental extraction surgery,
  • Other surgeries like: oral graft surgery, facial trauma, limited mouth opening ex: submandibular and facial abscess.

You may not qualify if:

  • Patient's refusal,
  • ASA III or more,
  • Intrinsic and idiopathic coagulopathy,
  • known allergy to any of the study medications,
  • furthermore, patients were excluded if they had severe hypoxemias due to sever cardiac or lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (6)

  • Mak PH, Ooi RG. Submental intubation in a patient with beta-thalassaemia major undergoing elective maxillary and mandibular osteotomies. Br J Anaesth. 2002 Feb;88(2):288-91. doi: 10.1093/bja/88.2.288.

    PMID: 11883389BACKGROUND

  • Allahyary E, Ghaemei SR, Azemati S. Comparison of six methods for predicting difficult intubation in obstetric patients. Iran Red Crescent Med J. 2008;10:197-204.

    BACKGROUND

  • Fontanarosa PB, Goldman GE, Polsky SS, Schuckman HA, Poyle M. Sitting oral-tracheal intubation. Ann Emerg Med. 1988 Apr;17(4):336-8. doi: 10.1016/s0196-0644(88)80775-3.

    PMID: 3354936BACKGROUND

  • Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.

    PMID: 23364566BACKGROUND

  • Wheeler M, Ovassapian A. Fiberoptic endoscopy-aided techniques. In: Benumof's airway management: principles and practice, 2nd ed., vol. 27(5). Mosby Elsevier Philadelphia; 2010. p. 461-67.

    BACKGROUND

  • Murphy MF. Applied functional anatomy of the airway. In: Manual of emergency airway management, 3rd ed., vol. 3(2). USA: Lippincott Williams & Wilkins; 2008.p. 37-46.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 19, 2022

First Posted

June 1, 2022

Study Start

July 1, 2022

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations

EG(1)