NCT03003585

Brief Summary

In this study, the investigators aimed to compare the effects of direct laryngoscopic and fiberoptic endotracheal intubation on intraocular pressure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

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

December 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

December 22, 2016

Last Update Submit

April 4, 2017

Conditions

Intraocular PressureIntubation Complication

Keywords

intraocular pressuredirect laryngoscopyfiberoptic bronchoscopy

Outcome Measures

Primary Outcomes (4)

  • Systolic blood pressure

    From Beginning of Anesthesia induction to 5th minutes of intubation

  • Heart rate

    From Beginning of Anesthesia induction to 5th minutes of intubation

  • Adverse events

    within the first 24 hour after surgery

  • Intraocular pressure

    From Beginning of Anesthesia induction to 5th minutes of intubation

Study Arms (2)

Fiberoptic bronchoscopy

ACTIVE COMPARATOR

Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.

Other: Fiberoptic bronchoscope

Direct laryngoscopy

ACTIVE COMPARATOR

Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.

Other: Direct laryngoscope

Interventions

Direct laryngoscopeOTHER

This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.

Direct laryngoscopy
Fiberoptic bronchoscopeOTHER

This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.

Fiberoptic bronchoscopy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA (American Society of Anesthesiologist) Grade 1-2,
  • Mallampati score 1 or 2,
  • Age between 18 to 65
  • Patient planned to undergo nonopthalmic surgery.

You may not qualify if:

  • Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, ASA Grade III and IV, BMI more than 35,
  • Patients with difficult intubation,
  • Patients undergoing obstetrical surgery and propofol, fentanyl, rocuronium contraindicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 28, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 4, 2017

Last Updated

April 5, 2017

Record last verified: 2017-04