Perioperative Diaphragmatic Ultrasound as Predictive Index of Atelectasis in Bariatric Surgery

NCT04701541 | Unknown

• 1 other identifier: ECODIABAS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the Authors assume that peri-operative changes in DIA are predictive of postoperative atelectasis, thus providing a clinically useful tool to stratify the need for high-intensity monitoring, including admission to intensive care. Aim of this prospective observational study, in obese patients undergoing sleeve gastrectomy, is to evaluate the relationship between pre to postoperative changes in US-DIA and PaO2/FiO2.

Conditions

Postoperative Pulmonary Atelectasis; Morbid Obesity

Keywords

Atelectasis; Diaphragmatic Inspiratory Amplitude; Obesity

Outcome Measures

Primary Outcomes (1)

• Correlation between diaphragmatic excursion and post-operative atelectasis

  to detect the relationship between perioperative changes in DIA, (unit of measurement "millimeters") finally expressed as percentage differences at the baseline, during forced breath and occurrence and severity of postoperative atelectasis (evaluated through PaO2/FiO2 R) at 240 min after extubation (T2), view with haemogasanalytic measurement.

  240 minutes

Secondary Outcomes (5)

• amount of neuromuscular blockers

  During surgery

• difference in pre and postoperative DIA during calm breathing

  During surgery + 1 hour post-surgery

• incidence rate of pneumonia on the second postoperative day

  2 days

• hospitalization duration

  4 days

• need for hospitalization in postoperative ICU

  4 days

Study Arms (1)

Obese Patients undergoing Bariatric Surgery

OTHER

Obesity is a progressively growing morbid condition in the world, and given the direct relationship between body mass index (BMI) and costs, this has a major impact on economic and health policy. Obese patients undergoing bariatric surgery are at high risk for postoperative respiratory complications. In these patients, postoperative respiratory complications are related to various pathophysiological mechanisms that include: decreased lung volumes, respiratory muscle dysfunction and atelectasis. Demographic (age, gender, BMI) and clinical features of the population included: ASA, comorbidity and pre and postoperative respiratory function \[PaO2/FiO2, haemogasanalysis (EGA)\]. Ultrasound evaluation of DIA was performed. T0: preoperative within 24h before surgery: DIA, haemogasanalysis; T1: Post operation: 60 min after extubation: Aldrete Score, DIA, EGA; T2: Post operation: 240 min after extubation: Aldrete, EGA.

Device: Diaphragmatic Ultrasound

Interventions

Diaphragmatic Ultrasound DEVICE

Diaphragmatic ultrasound is non-invasive, portable, quick to perform, with a linear relationship between diaphragmatic movement and inspired volume. In eligible patients, a preoperative baseline ultrasound evaluation of the diaphragm and lungs is accomplished. Evaluation will be performed by a single operator, blinded to the arterial blood gas analysis values. In a semi recumbent position, patients will be asked to rest and breath quietly. An anterior approach will be carried out applying freehand transducer on abdomen at the right midclavicular line immediately below the costal margin with firm pressure, steering in cranial direction. A B-mode transverse scanning will be performed looking across the liver with gallbladder in the middle. Measurements will be recorded by the M-mode frozen images. The M-mode modality will be used to study DIA. The best sinusoidal curve will be considered for measurements.

Also known as: Ultrasound-based Diaphragmatic Inspiratory Amplitude, ECO-DIA

Obese Patients undergoing Bariatric Surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• morbid obesity undergoing bariatric surgery (BMI \>30 Kg/m2)

You may not qualify if:

• Heart Failure
• Neuromuscular Diseases
• Previous Thoracic Surgery,
• American Society of Anesthesiology physical (ASA) status \>III.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Hospital Policlinico Umberto I of Rome

Roma, 00155, Italy

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Pulmonary Atelectasis; Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Alessandri

  Emergency and Acceptance Depart., Anaesth. and Critical Areas, P. Umberto I

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Alessandri

CONTACT

0649978024; francesco.alessandri@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Level I Medical Director, MD, PhD

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: January 8, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: May 31, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)