NCT04269564

Brief Summary

Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting. in our current study, we are trying to reach the optimum PEEP in laparoscopic bariatric patients to prevent postoperative collapse and atlectasis with simple non-invasive procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

February 3, 2020

Last Update Submit

August 19, 2020

Conditions

Atelectasis, Postoperative Pulmonary

Outcome Measures

Primary Outcomes (1)

  • efficacy of lung ultrasound in optimizing peep

    to evaluate the effect of lung ultrasound in optimizing peep in obese patients undergoing laparoscopic surgeries on the Incidence of intraoperative hypoxia and atlectasis

    intraoperative and early postoperative first 24 hours after recovery from anaesthesia

Secondary Outcomes (1)

  • effect on early postoperative oxygenation

    24 hours postoperative

Study Arms (2)

group A

NO INTERVENTION

Group A patients received the standard ventilation protocol as follows: volume-controlled ventilation mode, with VT 6 ml/kg of ideal body weight, inspiratory : expiratory ratio 1 : 2, a PEEP of 4 cmH2O, and respiratory rate 10-12 breaths/min that will be adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35 and 40 mmHg and inspired oxygen fraction of 0.5.

group B

ACTIVE COMPARATOR

Patients in group B received the standard ventilation protocol with stepwise peep until end of surgery and extubation.

Device: stepwise PEEP

Interventions

stepwise PEEPDEVICE

* a PEEP of 4 cmH2O will be used after intubation till 5 minutes after pneumoperitonium, and adjusted in a step wise approach after lung ultrasound by adding 2 cmH2O, repeating ultrasound 5 minutes after every change in peep till no lung collapse is detected by lung ultrasound with a maximal peep of 10 cmH2O, or if hemodynamic instability occurs. * Lung ultrasound examination will be performed at a minimum three times in each patient; the first will be performed 1 min after starting mechanical ventilation of the lungs, 5 minutes after pneumoperitonium, 5 min after every peep increase in stepwise peep group and the last time at the end of the surgery. We define anaesthesia-induced atelectasis to be significant if any region has a consolidation score of ≥ 2.

group B

Eligibility Criteria

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

You may qualify if:

  • they are between 18 and 65 years of age
  • BMI more than 35
  • patients with normal respiratory functions
  • ASA 1 or 2

You may not qualify if:

  • Previous lung surgery
  • Bronchial asthma
  • Contralateral lung bullae 4. Uncompensated cardiac disease (NYHA class 3 or 4) 5. Obstructive or restrictive lung disease 6. Patients on home oxygen therapy 7. Hemodynamic instability and increased intracranial pressure 8. In adittion , any patient who developes hemodynamic instability (MAP \<60mmHg) or hypoxia (Po2 less than 60) during the study will excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Cairo, 11562, Egypt

Location

Related Publications (3)

  • Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.

    PMID: 30253139BACKGROUND

  • Lobo B, Hermosa C, Abella A, Gordo F. Electrical impedance tomography. Ann Transl Med. 2018 Jan;6(2):26. doi: 10.21037/atm.2017.12.06.

    PMID: 29430443BACKGROUND

  • Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.

    PMID: 27669555BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia lecturer

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 17, 2020

Study Start

February 20, 2020

Primary Completion

August 18, 2020

Study Completion

August 19, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations

EG(1)