NCT00620386

Brief Summary

We studied intubating conditions and hemodynamic changes during endotracheal intubation employing either Bonfils intubating fiberscope or the conventional Macintosh laryngoscopy in 80 healthy patients candidates for elective surgery requiring endotracheal intubation. We omitted neuromuscular blocking drugs from the induction regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

October 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
Last Updated

February 21, 2008

Status Verified

February 1, 2008

Enrollment Period

8 months

First QC Date

February 8, 2008

Last Update Submit

February 8, 2008

Conditions

Endotracheal IntubationHemodynamicsNeuromuscular Blockade

Keywords

Intubating conditionsBonfils intubation fiberscopeMacintosh laryngoscopeneuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • intubating conditions

    7 months

Secondary Outcomes (3)

  • mean arterial pressure (MAP)

    7 months

  • heart rate (HR)

    7 months

  • Pulse Oxygen Saturation (SpO2)

    7 months

Study Arms (2)

1

EXPERIMENTAL

Intubation with Bonfils intubating fiberscope

Device: Bonfils

2

ACTIVE COMPARATOR

Intubation with Macintosh laryngoscopy

Device: Macintosh

Interventions

BonfilsDEVICE

Endotracheal intubation using Bonfils Intubating Fiberscope

1
MacintoshDEVICE

Endotracheal intubation using Macintosh laryngoscopy

2

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • American Society of Anesthesiology (ASA) physical status was class I or II
  • body mass index (BMI) \< 30
  • ability to assume the 'sniffing' position

You may not qualify if:

  • smokers
  • drug users
  • pregnant
  • expected to present difficult intubation
  • history of oesophageal reflux
  • any systemic or airway disease
  • known allergy to the protocol medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sina Hospital

Tehran, Tehran Province, Iran

Location

Study Officials

  • Reza Shariat Moharari, MD

    Tehran University of Medical Sciences

    STUDY DIRECTOR

  • Eiman Rahimi, MD

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 21, 2008

Study Start

October 1, 2006

Primary Completion

June 1, 2007

Study Completion

August 1, 2007

Last Updated

February 21, 2008

Record last verified: 2008-02

Locations

IR(1)