NCT06219460

Brief Summary

Two types of face masks : cuffed and uncuffed were evaluated for artificial ventilation in obese patients. After induction to anesthesia patients were ventilated with both types of masks using anesthesia machine with the same settings: Tital Volume of 500 ml, respiratory rate of 12/min. The inspired and expired volume was measured using anesthesia machine volumeter, The difference between inspired and expired volume was counted. The comparison between two types of masks was performed taking into consideration several parameters: type of obesity, gender, age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration 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

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 2, 2024

Last Update Submit

January 12, 2024

Conditions

Obesity, Morbid

Keywords

morbid obesityface mask ventilation

Outcome Measures

Primary Outcomes (1)

  • Sealing of face masks measured by difference of inspired tidal volume and expired volume

    Sealing of cuffed or uncuffed masks during face mask ventilation in obese patients measred by anesthesia machine

    immediatethrough study completion

Study Arms (2)

Cuffed face amsk

EXPERIMENTAL

Ventilation using cuffed face mask

Other: Ventilation using two types of face masks

Uncuffed face mask

EXPERIMENTAL

Ventilation using uncuffed face mask

Other: Ventilation using two types of face masks

Interventions

Ventilation using two types of face masksOTHER

ventilation using two types of face mask

Cuffed face amskUncuffed face mask

Eligibility Criteria

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

You may qualify if:

  • obesity
  • scheduled for elective surgery under general anesthesia

You may not qualify if:

  • predicted difficult intubation
  • predicted difficult face-mask ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lodz, Poland

Lodz, 90-153, Poland

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tomasz Gaszynski, Prof

    Medical University of Lodz, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr hab.

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 23, 2024

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

December 1, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)