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Single Lung Ventilation Versus Two Lung Ventilation

Primary Purpose

Hypoxemia, Single Lung Ventilation

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Single lung ventilation by double lumen endotracheal tube

Two lung ventilation by conventional single lumen endotracheal tube

About this trial

This is an interventional other trial for Hypoxemia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Aun Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Single lung ventilation

Two lung ventilation

Arm Description

Using double lumen endotracheal tube and lung isolation

Using conventional single lumen endotracheal tube and intermittent two lung ventilation

Outcomes

Primary Outcome Measures

Incidence of hypoxemia

Hypoxemia in single and two lung ventilation by serial arterial blood gases

Secondary Outcome Measures

Incidence of failure to correct Hypoxemia in single lung ventilation

Stop lung isolation and procedure using two lung ventilation to correct hypoxia

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

Incidence of post operative complications

Any associated complications

Full Information

NCT ID

NCT04981990

First Posted

April 22, 2021

Last Updated

August 24, 2021

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04981990

Brief Title

Single Lung Ventilation Versus Two Lung Ventilation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

August 25, 2021 (Actual)

Study Completion Date

August 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxemia, Single Lung Ventilation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two equal groups: the first group undergoing lung surgeries with single lung ventilation by double lumen endotracheal tube, the second group undergoing lung surgeries with two lung ventilation using conventional single lumen endotracheal tube

Masking

Participant

Masking Description

The patients will not know whether they are in the first or second group

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single lung ventilation

Arm Type

Active Comparator

Arm Description

Using double lumen endotracheal tube and lung isolation

Arm Title

Two lung ventilation

Arm Type

Active Comparator

Arm Description

Using conventional single lumen endotracheal tube and intermittent two lung ventilation

Intervention Type

Procedure

Intervention Name(s)

Single lung ventilation by double lumen endotracheal tube

Intervention Description

Single lung ventilation using double lumen endotracheal tube and isolation of the operated lung during surgery to create ideal surgical field

Intervention Type

Procedure

Intervention Name(s)

Two lung ventilation by conventional single lumen endotracheal tube

Intervention Description

Intermittent two lung ventilation so that no significant hypoxia occurs with creating optimum surgical field

Primary Outcome Measure Information:

Title

Incidence of hypoxemia

Description

Hypoxemia in single and two lung ventilation by serial arterial blood gases

Time Frame

Intraoperative to first 24 hours post operative

Secondary Outcome Measure Information:

Title

Incidence of failure to correct Hypoxemia in single lung ventilation

Description

Stop lung isolation and procedure using two lung ventilation to correct hypoxia

Time Frame

Intraoperative

Title

Incidence of failure of two lung ventilation to create optimum surgical field

Description

Frequent stopping of ventilation and the surgent can't access the surgical field easily

Time Frame

Intraoperative

Title

Incidence of post operative complications

Description

Any associated complications

Time Frame

First 24 hours post operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Esraa Abdellatif

Phone

01119895491

esraa301993@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Esraa Abdellatif, M.B., B.Ch.

Organizational Affiliation

Anesthesiology department

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Omar El safty, MD

Organizational Affiliation

Anesthesiology department

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Salwa Omar, MD

Organizational Affiliation

Anesthesiology department

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohamed Taeimah, MD

Organizational Affiliation

Anesthesiology department

Official's Role

Study Director

Facility Information:

Facility Name

Aun Shams University Hospitals

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Single Lung Ventilation Versus Two Lung Ventilation

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