NCT04704596

Brief Summary

The aim of this study is to evaluate The role of transthoracic lung US as a clinical tool in Comparison to dynamic lung compliance for detection of optimum PEEP for obese patients undergoing laparoscopic gastric sleeve surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

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

December 16, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

January 7, 2021

Last Update Submit

July 7, 2022

Conditions

Mechanical Ventilation During Anesthesia

Outcome Measures

Primary Outcomes (1)

  • detection of the optimum PEEP which is measured in mmHg

    the optimum PEEP will be detected after alveolar recruitment either by dynamic lung compliance or by lung ultarsound views

    intraoperative period

Secondary Outcomes (1)

  • prevention of postoperative pulmonary complications

    1st 24 hour

Study Arms (2)

dynamic lung compliance for detection of optimum PEEP

ACTIVE COMPARATOR

detection of optimum PEEP by measurement of the dynamic lung compliance (by the ventilator machine) after lung recruitment

Device: anesthesia ventilator machine

Lung ultrasound for detection of the optimum PEEP

ACTIVE COMPARATOR

Lung ultrasound will be used to detect the optimum PEEP after lung recruitment

Device: lung ultrasound

Interventions

anesthesia ventilator machineDEVICE

dynamic lung compliance measurements will be used for detection of the optimum PEEP after alveolar recruitment

dynamic lung compliance for detection of optimum PEEP
lung ultrasoundDEVICE

lung ultrasound views will be used for detection of the optimum PEEP after alveolar recruitment

Lung ultrasound for detection of the optimum PEEP

Eligibility Criteria

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

You may qualify if:

  • physical status American Society of Anesthesiologist(ASA) I or II

You may not qualify if:

  • Patients refuse ASA physical status more \> II
  • Patients with pre-existing significant pulmonary disease with abnormalities in spirometry, previous lung surgery, home oxygen therapy and significant cardiac dysfunction.
  • Patients with pulmonary hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

December 16, 2020

Primary Completion

January 15, 2022

Study Completion

January 20, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Locations

EG(1)