Single Lung Ventilation Versus Two Lung Ventilation

Single Lung Ventilation Versus Two Lung Ventilation in Video Assisted Lung Surgeries

Hypoxia in single lung ventilation versus two lung ventilation in video assisted lung surgeries

Study Overview

• Status: Recruiting
• Conditions: Hypoxemia; Single Lung Ventilation
• Intervention / Treatment: Procedure: Single lung ventilation by double lumen endotracheal tube; Procedure: Two lung ventilation by conventional single lumen endotracheal tube

Detailed Description

Incidence of hypoxia in single lung ventilation by double lumen endotracheal tube "of choice in lung surgeries" versus incidence of hypoxia in two lung ventilation by conventional single lumen endotracheal tube "intermittent two lung ventilation"

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esraa Abdellatif; Phone Number: 01119895491; Email: esraa301993@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Aun Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age group: Adult patients from age of 21 years to 60 years
• Sex: Both sexes
• ASA Classification: patients with ASA classification II, III.
• Elective lung surgeries using video assisted thoracoscopic surgeries.

Exclusion Criteria:

• Patients refuse to give informed consent.
• ASA Classification: ASA IV.
• Failure of thoracoscopic surgeries and continue as open thoracotomy
• Patients with ischemic heart diseases, where hypoxemia might be preexisting, or patient be more vulnerable to hypoxemia whatever the technique or time of hypoxia.
• Emergency lung surgeries.
• Patients underwent previous lung surgeries of any cause.
• Patients with pathology to the non-operated side.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single lung ventilation; Using double lumen endotracheal tube and lung isolation	Procedure: Single lung ventilation by double lumen endotracheal tube; Single lung ventilation using double lumen endotracheal tube and isolation of the operated lung during surgery to create ideal surgical field
Active Comparator: Two lung ventilation; Using conventional single lumen endotracheal tube and intermittent two lung ventilation	Procedure: Two lung ventilation by conventional single lumen endotracheal tube; Intermittent two lung ventilation so that no significant hypoxia occurs with creating optimum surgical field

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxemia	Hypoxemia in single and two lung ventilation by serial arterial blood gases	Intraoperative to first 24 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of failure to correct Hypoxemia in single lung ventilation	Stop lung isolation and procedure using two lung ventilation to correct hypoxia	Intraoperative
Incidence of failure of two lung ventilation to create optimum surgical field	Frequent stopping of ventilation and the surgent can't access the surgical field easily	Intraoperative
Incidence of post operative complications	Any associated complications	First 24 hours post operative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Esraa Abdellatif, M.B., B.Ch., Anesthesiology Department; Study Chair: Omar El safty, MD, Anesthesiology Department; Study Director: Salwa Omar, MD, Anesthesiology Department; Study Director: Mohamed Taeimah, MD, Anesthesiology Department

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 25, 2021
• Study Completion (Anticipated): August 25, 2021

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: Anesth

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All study data will be open to other researchers
• IPD Sharing Time Frame: After finishing the study by the end of August 2021
• IPD Sharing Access Criteria: For any medical student or staff interested in topic without any other considerations
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes