Effect of Position and Pneumoperitoneum on Respiratory Mechanics and Transpulmonary Pressure During Laparoscopic Surgery

NCT03526003 | Unknown FDA Device

• 1 other identifier: 075-18
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an observational study measuring the esophageal pressure in anesthetized surgical patient undergoing changes in posture and pneumoperitoneum

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• Changes in esophageal pressure

  Effect of posture and pneumoperitoneum on esophageal pressure

  From immidiatly after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumoperitoneum

Study Arms (1)

Surgical patients

Adult patient scheduled for laparoscopic surgery under general anesthesia

Diagnostic Test: Measurement of esophageal pressure

Interventions

Measurement of esophageal pressure DIAGNOSTIC_TEST

Measurement of esophageal pressure during posture changes and pneumoperotoneum

Surgical patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective laparoscopic surgery aged between 20 and 80 years will be included. Each participant signed an informed consent. Exclusion criteria included respiratory pathology, a body mass index lower than 25 or higher than 45 kg/m2, esophageal pathology and previous esophageal or pulmonary operation.

You may qualify if:

• patients scheduled for laparoscopic surgery
• body mass index between 25 and 45

You may not qualify if:

• pregnancy
• contraindications for insertion of nasogastric tube

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Related Publications (2)

• Fish E, Novack V, Banner-Goodspeed VM, Sarge T, Loring S, Talmor D. The Esophageal Pressure-Guided Ventilation 2 (EPVent2) trial protocol: a multicentre, randomised clinical trial of mechanical ventilation guided by transpulmonary pressure. BMJ Open. 2014 Oct 6;4(9):e006356. doi: 10.1136/bmjopen-2014-006356.

  PMID: 25287106 BACKGROUND

• Plataki M, Hubmayr RD. Should mechanical ventilation be guided by esophageal pressure measurements? Curr Opin Crit Care. 2011 Jun;17(3):275-80. doi: 10.1097/MCC.0b013e328344dda6.

  PMID: 21326094 BACKGROUND

Central Study Contacts

Amit Lehavi, MD

CONTACT

972-50-20161419; amit.lehavi@gmail.com

Yaron Bar-Lavie, MD

CONTACT

972-50-2062027; y_barlavie@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Anesthesia

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: July 15, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2020
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share