NCT03693352

Brief Summary

Changes in body position during anesthesia can alter functional residual capacity and gas exchange. The monitoring of such changes in functional residual capacity is difficult at the bedside. The present study was designed to determine if volumetric capnography can detect changes in the functional residual capacity during surgery.

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 all trials

Timeline
Completed

Started Oct 2018

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

October 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

October 1, 2018

Last Update Submit

July 13, 2020

Conditions

Respiratory Physiological Phenomena

Outcome Measures

Primary Outcomes (1)

  • Functional Residual Capacity Measured by Capnography in Ventilated Patients

    Measurement of functional residual capacity with capnography with body positioning changes.

    6 hours

Study Arms (1)

Patients undergoing surgeries

Patients ASA 1-3, undergoing different types of general anesthesia that need postural changes like Trendelenburg and anti-Trendelenburg positioning.

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing general anesthesia for laparoscopic surgery

You may qualify if:

  • Written Inform Consent
  • Programmed surgery
  • Laparoscopic surgery
  • Supine position

You may not qualify if:

  • Emergency surgery
  • Chronic respiratory disease
  • Active smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Related Publications (2)

  • Albu G, Wallin M, Hallback M, Emtell P, Wolf A, Lonnqvist PA, Gothberg S, Petak F, Habre W. Comparison of static end-expiratory and effective lung volumes for gas exchange in healthy and surfactant-depleted lungs. Anesthesiology. 2013 Jul;119(1):101-10. doi: 10.1097/ALN.0b013e3182923c40.

    PMID: 23571638BACKGROUND

  • Tusman G, Wallin M, Acosta C, Santanera B, Portela F, Viotti F, Fuentes N, Hallback M, Suarez-Sipmann F. Positive end-expiratory pressure individualization guided by continuous end-expiratory lung volume monitoring during laparoscopic surgery. J Clin Monit Comput. 2022 Oct;36(5):1557-1567. doi: 10.1007/s10877-021-00800-2. Epub 2021 Dec 29.

    PMID: 34966951DERIVED

Study Officials

  • Gerardo Tusman, MD

    Hospital Privado de Comunidad de Mar del Plata

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 3, 2018

Study Start

October 1, 2018

Primary Completion

February 10, 2020

Study Completion

April 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)