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

NCT05268900 | Unknown DMC

• 1 other identifier: MD/ 21.10.553
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Colectomy

Keywords

ventilation; intracranial pressure; laparoscopy

Outcome Measures

Primary Outcomes (1)

• Changes in ONSD O(optic) N(nerve) S(sheath) D(diameter)

  ONSD is the acronym of O(optic) N(nerve) S(sheath) D(diameter), that ONSD is a non invasive method for measurement of intracranial pressure The optimal cutoff value has not been established, they vary between 4.85 and 5.9 mm and \>5.9 mm is a sure sign of increased intracranial tension

  Changes from baseline, till 30 minutes after recovery from anaesthesia

Secondary Outcomes (12)

• Heart rate

  Changes from baseline, till 30 minutes after recovery from anaesthesia

• Mean arterial blood pressure

  Changes from baseline, till 30 minutes after recovery from anaesthesia

• Peak airway pressure

  intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).

• Plateau airway pressure

  intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).

• mean airway pressure

  intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).

Study Arms (2)

Volume control ventilation group

PLACEBO COMPARATOR

Patients' lungs will be ventilated with volume control ventilation mode

Device: Volume control ventilation group

Pressure control ventilation-volume guaranteed group

ACTIVE COMPARATOR

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

Device: Pressure control ventilation-volume guaranteed group

Interventions

Volume control ventilation group DEVICE

Volume control ventilation mode

Volume control ventilation group

Pressure control ventilation-volume guaranteed group DEVICE

Pressure control ventilation-volume guaranteed mode

Pressure control ventilation-volume guaranteed group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanaa M El Bendary

  Assistant professor, MD anesthesia Department, Faculty of Medicine,

  STUDY DIRECTOR

• Doaa G Diab

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

  STUDY CHAIR

Central Study Contacts

Hanaa M El Bendary

CONTACT

00201005781768; Hanaa_elbendary@yahoo.com

Doaa G Diab

CONTACT

00201069507088; Basmalg@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 7, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: will be available within 6 months of study completion
• Access Criteria: data access requests will be reviewed by an external independent review panel. requestors will be required to sign a data access agreement

Locations

EG (1)