Ventilation Modes Effect on Intracranial Pressure During Laparoscopic Colectomy by Optic Nerve Sheath Diameter

NCT ID: NCT05268900

Last Updated: 2022-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients who undergo laparoscopic surgery often experience increased intracranial pressure (ICP). In laparoscopic colectomy surgery, the duration always exceeds 2h with more liability to changes in arterial blood gases, hemodynamics, also the patient is in Trendelenburg position about 30° head down, Trendelenburg position is believed to create changes in hemodynamics, respiratory mechanics, metabolic response, and ICP as it affects vital organs especially if steep positioning. Various modes of mechanical ventilation have been experimented to achieve good intraoperative oxygenation which may cause changes in arterial blood gas values and hemodynamic parameters that might lead to changes in the ICP. In this study we will measure ONSD, basal, intraoperative, and in the PACU to evaluate the effect of different ventilation modes (both VCV mode and PCV-VG mode) on intracranial pressure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of the current study is to compare the effect of volume control ventilation (VCV) versus pressure control ventilation-volume guaranteed (PCV-VG) as modes of mechanical ventilation on ICP by US guided ONSD measurement during laparoscopic colectomy,

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic Colectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Volume control ventilation group

Patients' lungs will be ventilated with volume control ventilation mode

Group Type PLACEBO_COMPARATOR

Volume control ventilation group

Intervention Type DEVICE

Volume control ventilation mode

Pressure control ventilation-volume guaranteed group

patients' lungs will be ventilated with Pressure control ventilation-volume guaranteed mode

Group Type ACTIVE_COMPARATOR

Pressure control ventilation-volume guaranteed group

Intervention Type DEVICE

Pressure control ventilation-volume guaranteed mode

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Volume control ventilation group

Volume control ventilation mode

Intervention Type DEVICE

Pressure control ventilation-volume guaranteed group

Pressure control ventilation-volume guaranteed mode

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body mass index less than 30
* American Society of Anesthesiologist physical class I -III.

Exclusion Criteria

* Patient refusal
* operative time \< 2 hour (h)
* Patients with preexisting eye disease.
* History of eye surgery
* Optic nerve disease.
* Causes of elevated ICP.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hanaa M El Bendary

Role: STUDY_DIRECTOR

Assistant professor, MD anesthesia Department, Faculty of Medicine,

Doaa G Diab

Role: STUDY_CHAIR

professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University

Al Mansurah, DK, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hanaa M El Bendary

Role: CONTACT

00201005781768

Doaa G Diab

Role: CONTACT

00201069507088

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hanaa M El Bendary, MD

Role: primary

00201005781768

Doaa G Diab, MD

Role: backup

00201069507088

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MD/ 21.10.553

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.