Diaphragm Functions in Bariatric Surgeries

NCT04828408 | Completed

• 1 other identifier: 2019/02-16.derya
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is an important public health problem all over the world, and its prevalence is increasing every year. In obesity, significant changes occur in the mechanical properties of the lungs and chest wall due to fat deposits in the mediastinum and abdominal cavities. Upper abdominal surgical procedures usually cause impairment of respiratory functions by affecting respiratory volume and capacity. The risk of postoperative pulmonary complications increases with the decrease in restrictive capacities, hypoxemia, and increased respiratory work. It may also be due to causes such as diaphragm dysfunction, postoperative pain, and surgical incision.Ultrasonography (USG) is a method accepted for evaluating the normal and pathological conditions of the diaphragm. M-mode is used to evaluate the anatomical and functional disorders of the diaphragm. The diaphragm evaluation is performed with the anterior approach in the supine position and with different respiratory maneuvers (sniffing, deep inspiration, normal inspiration). The aim of the study was to evaluate the diaphragm function by using USG and spirometry methods in patients who underwent bariatric surgery and to investigate the effect of postoperative pain score on diaphragm function.

Conditions

Diaphragm Disease; Pulmonary Function Test; Ultrasonography; Bariatric Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• diaphragm function

  change from baseline in diaphragm inspiratory amplitude at 24 hours

  time from 10 minutes before anesthesia to 24 hours postoperatively

Interventions

Bariatric surgery PROCEDURE

Patients with a body mass index (BMI) ˃35, age interval of 18-65, and ASA score II-III undergoing laparoscopic bariatric surgery were included in the study. Patients with neuromuscular, cardiopulmonary, and cerebrovascular diseases, phrenic nerve damage or diaphragm paralysis, those who have undergone thoracic surgery, who could not communicate, who did not want to participate in the study, who used alcohol, those who needed postoperative intensive care, those who had surgical complications during surgery, and those who were switched to open surgery were not included in the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic bariatric surgery

You may qualify if:

• Patients with a body mass index (BMI) ˃35,
• age interval of 18-65,
• ASA score II-III undergoing laparoscopic bariatric surgery

You may not qualify if:

• Patients with neuromuscular, cardiopulmonary, and cerebrovascular diseases,
• phrenic nerve damage or diaphragm paralysis,
• those who have undergone thoracic surgery,
• who could not communicate,
• who did not want to participate in the study,
• who used alcohol,
• those who needed postoperative intensive care,
• those who had surgical complications during surgery,
• those who were switched to open surgery

Sponsors & Collaborators

• Turkiye Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (1)

University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, 16290, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: March 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 2, 2019
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)