NCT04509960

Brief Summary

different ways of airway management in elective minor surgeries of geriatric patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 13, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

June 13, 2020

Last Update Submit

January 4, 2021

Conditions

Comparison of Different Laryngeal Mask Wearing Methods

Keywords

laryngeal mask

Outcome Measures

Primary Outcomes (2)

  • laryngeal mask placement

    To evaluate the best fiberoptic bronchoscopic view while insertion of pro-Seal laryngeal mask either in a classic way, or with the help of laryngoscope. The fibreoptic evaluation Includes 4, only vocal cords visible; 3, vocal cords plus posterior epiglottis visible 2, vocal cords plus anterior epiglottis visible ; 1, vocal cords not seen.

    First minute after laryngeal mask insertio

  • complications of laryngeal mask insertion

    complications like sore throat, hoarseness, nausea, and vomiting or Bloodstain on the laryngeal mask. we simply asked patients about them

    Complications will be evaluated within 1 hour after patient recovery.

Secondary Outcomes (7)

  • hemodynamic response

    Before putting on the Layngeal mask, it will record in beats / minute at 5 minutes for 1 minute and 20 minutes after wearing

  • insertion time

    The investigator will record the insertion time in seconds from the moment the laryngeal mask airway passes the incisors until the end-tidal CO2 is visible.

  • respiratory dynamics

    The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute

  • hemodynamic responce

    Before putting on the Layngeal mask, it will record in mm Hg at 5 minutes for 1 minute and 20 minutes after wearing

  • oxygen saturation

    Before putting on the Layngeal mask, it will record in %SpO2 at 5 minutes for 1 minute and 20 minutes after wearing

  • +2 more secondary outcomes

Study Arms (2)

proseal laryngeal mask insertion

NO INTERVENTION

no intervention

proseal laryngeal mask insertion with laryngoscope

EXPERIMENTAL

with the help of direct laryngoscopy

Device: direct laryngoskopy

Interventions

direct laryngoskopyDEVICE

Proseal Laryngeal mask inserted with direct laryngoskopy

proseal laryngeal mask insertion with laryngoscope

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I or II or III
  • Who were scheduled to minor elective ambulatory surgery (e.g. urology operations)
  • Patients undergoing general anesthesia
  • Those who are planned to wear a laryngeal mask for surgical procedure

You may not qualify if:

  • patients with full stomach
  • A history of gastric reflux
  • A history of convulsions, cardiovascular or neuromuscular disease
  • Allergies to the study drugs
  • obese (Body mass index (BMI) ≥ 40 kg / m2)
  • suspected difficult airway and hyper-reactive airway disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Siences Diskapi Yildirim Beyazit T&R hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Chandan SN, Sharma SM, Raveendra US, Rajendra Prasad B. Fiberoptic assessment of laryngeal mask airway placement: a comparison of blind insertion and insertion with the use of a laryngoscope. J Maxillofac Oral Surg. 2009 Jun;8(2):95-8. doi: 10.1007/s12663-009-0025-8. Epub 2009 Aug 11.

    PMID: 23139483BACKGROUND

  • Kim GW, Kim JY, Kim SJ, Moon YR, Park EJ, Park SY. Conditions for laryngeal mask airway placement in terms of oropharyngeal leak pressure: a comparison between blind insertion and laryngoscope-guided insertion. BMC Anesthesiol. 2019 Jan 5;19(1):4. doi: 10.1186/s12871-018-0674-6.

    PMID: 30611202BACKGROUND

  • Choo CY, Koay CK, Yoong CS. A randomised controlled trial comparing two insertion techniques for the Laryngeal Mask Airway Flexible in patients undergoing dental surgery. Anaesthesia. 2012 Sep;67(9):986-90. doi: 10.1111/j.1365-2044.2012.07167.x. Epub 2012 Jun 11.

    PMID: 22686571BACKGROUND

Central Study Contacts

Filiz Akaslan

CONTACT

03125962553flz_karaca@hotmail.com

Study Design

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

Study Record Dates

First Submitted

June 13, 2020

First Posted

August 12, 2020

Study Start

January 15, 2021

Primary Completion

March 30, 2021

Study Completion

April 30, 2021

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)