NCT03938402

Brief Summary

Positive end-expiratory pressure (PEEP) is sometimes used during perioperative period, as it has favourable effects on lung mechanics. Unfortunately, it has some negative effects on the patients, like increased intraabdominal, intrathoracic, intracranial and intraocular pressures. In this study the investigators aimed to investigate the effects of different PEEP levels on the patients' intraocular and intracranial pressures. Intraocular pressure will be measured by ocular tonometry, and intracranial pressure will be estimated by optic nerve sheath diameter measurement. The measurements will be performed in the operating room in the patients undergoing laparotomic surgery.

Trial Health

57
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Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

April 27, 2019

Last Update Submit

November 22, 2021

Conditions

Intraocular PressureIntracranial PressurePositive End-expiratory Pressure

Keywords

Intraocular pressureOptic nerve sheath diameterPositive end-expiratory pressure

Outcome Measures

Primary Outcomes (2)

  • Changes in intraocular pressure

    The physiological value for intraocular pressure is 10-20 mm Hg. Changes in intraocular pressure will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.

    Throughout the operation (usually about 1.5 hours).

  • Changes in optic nerve sheath diameter

    Changes in optic nerve sheath diameter will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.

    Throughout the operation (usually about 1.5 hours).

Study Arms (3)

PEEP 5

EXPERIMENTAL
Other: Positive end-expiratory pressure

PEEP 10

EXPERIMENTAL
Other: Positive end-expiratory pressure

PEEP 15

EXPERIMENTAL
Other: Positive end-expiratory pressure

Interventions

Positive end-expiratory pressureOTHER

Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.

PEEP 10PEEP 15PEEP 5

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing laparotomy for gastrointestinal surgery
  • American Society of Anesthesiologists (ASA) 1 or 2 physical status
  • Elective surgery

You may not qualify if:

  • Patients with glaucoma
  • ASA 3 or over physical status
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Ruslan Abdullayev

    Marmara University School of Medicine, Dep of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

April 27, 2019

First Posted

May 6, 2019

Study Start

July 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

December 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)