NCT05026671

Brief Summary

Although many researchers would agree that obesity per se is not a risk factor for difficult intubation, there are many well known obesity-related challenges in airway management including difficulty with mask ventilation, more frequent and rapid oxygen desaturation, increased oxygen consumption, and increased sensitivity to the respiratory depressant effects of anesthetic and analgesic drugs. Hence, in these conditions, rapid and nontraumatic intubation gain higher interest. There is controversy about using videoaryngoscopy (VL) in obese patients in these difficult situations. The primary aim of this study is to compare, in terms of intubation time, VL,VL plus stylet and direct-laryngoscopy(DL) plus stylet combination with DL alone in obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

November 25, 2022

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

August 22, 2021

Last Update Submit

November 23, 2022

Conditions

Intubation Time

Keywords

Obese PatientsStylet ProceduresVideo LaryngoscopeFirst-attempt intubation

Outcome Measures

Primary Outcomes (1)

  • Intubation Time Using a Stop Watch

    The timing measurements will begin once the laryngoscope blade will be placed in the patient's mouth and ended when an end-tidal CO2 tracing will be detected.

    Up to 3 minutes

Secondary Outcomes (9)

  • Heart Rate

    Before induction to 3 min after intubation

  • Mean Arterial Pressure:

    Before induction to 3 min after intubation

  • Saturation

    Before induction to 3 min after intubation

  • Incidence of severe complications following intubation

    During intubation to 3 min after intubation

  • Glottis View Using the Cormack Lehane Score

    Up to 1 minute

  • +4 more secondary outcomes

Study Arms (4)

Group DL

ACTIVE COMPARATOR

The control group consists of intubating the trachea with an endotracheal tube alone (without stylet).

Procedure: Endotracheal Tube Alone

Group DLS

EXPERIMENTAL

The Experimental group consists of intubating the trachea with an endotracheal tube + stylet.

Procedure: Endotracheal Tube+ Stylet

Group VL

EXPERIMENTAL

The Experimental consists of intubating the trachea with an endotracheal tube + Video-laryngoscope

Procedure: Endotracheal Tube + Video-laryngoscope

Group VLS

EXPERIMENTAL

The Experimental consists of intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope

Procedure: Endotracheal tube + stylet with Video-laryngoscope

Interventions

Endotracheal Tube AlonePROCEDURE

Intubating the trachea with an endotracheal tube alone ( without stylet).

Group DL
Endotracheal Tube+ StyletPROCEDURE

Intubating the trachea with an endotracheal tube + stylet.

Group DLS
Endotracheal Tube + Video-laryngoscopePROCEDURE

Intubating the trachea with an endotracheal tube + Video- laryngoscope

Group VL
Endotracheal tube + stylet with Video-laryngoscopePROCEDURE

Intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope

Group VLS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a documented body mass index (BMI) of ≥ 30.
  • Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
  • Willingness and ability to sign an informed consent document 18 - 80 years of age

You may not qualify if:

  • Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
  • Patients with a history of facial abnormalities, oral-pharyngeal cancer, or reconstructive surgery
  • Emergency surgeries
  • Pregnancy
  • Any other conditions or use of any medication which may interfere with the conduct of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Study Officials

  • Betul Basaran, MD, DESA

    Karaman Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participant and the healthcare worker who will perform preoperative and postoperative visit will be blinded to randomized study group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2021

First Posted

August 30, 2021

Study Start

September 1, 2021

Primary Completion

April 18, 2022

Study Completion

April 30, 2022

Last Updated

November 25, 2022

Record last verified: 2021-08

Locations

TU(1)