Single Lung Ventilation Versus Two Lung Ventilation

NCT04981990 | Unknown DMC

• 1 other identifier: Anesth
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoxemia; Single Lung Ventilation

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxemia

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

  Intraoperative to first 24 hours post operative

Secondary Outcomes (3)

• Incidence of failure to correct Hypoxemia in single lung ventilation

  Intraoperative

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

  Intraoperative

• Incidence of post operative complications

  First 24 hours post operative

Study Arms (2)

Single lung ventilation

ACTIVE COMPARATOR

Using double lumen endotracheal tube and lung isolation

Procedure: Single lung ventilation by double lumen endotracheal tube

Two lung ventilation

ACTIVE COMPARATOR

Using conventional single lumen endotracheal tube and intermittent two lung ventilation

Procedure: Two lung ventilation by conventional single lumen endotracheal tube

Interventions

Single lung ventilation by double lumen endotracheal tube PROCEDURE

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

Single lung ventilation

Two lung ventilation by conventional single lumen endotracheal tube PROCEDURE

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

Two lung ventilation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Aun Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esraa Abdellatif, M.B., B.Ch.

  Anesthesiology department

  PRINCIPAL INVESTIGATOR

• Omar El safty, MD

  Anesthesiology department

  STUDY CHAIR

• Salwa Omar, MD

  Anesthesiology department

  STUDY DIRECTOR

• Mohamed Taeimah, MD

  Anesthesiology department

  STUDY DIRECTOR

Central Study Contacts

Esraa Abdellatif

CONTACT

01119895491; esraa301993@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will not know whether they are in the first or second group
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia resident, principal investigator

Model Details: 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

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: July 29, 2021
• Study Start: March 1, 2021
• Primary Completion: August 25, 2021
• Study Completion: August 25, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After finishing the study by the end of August 2021
• Access Criteria: For any medical student or staff interested in topic without any other considerations

Locations

EG (1)