Comparing The Outcome Of High Flow Oxygen Versus Conventional Oxygen In Extubated Patients After Lung Resection.

NCT05511636 | Unknown

• 1 other identifier: Cardiothoracic academy
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Conventional oxygen therapy (COT) is the main supportive treatment administered to patients postoperative after planned extubation and has conventionally been delivered using nasal prongs, cannula or masks. However, the maximal oxygen flow rates that these devices can deliver are limited. Being diluted by the ambient air which reduces the fraction of inspired oxygen is not only the main concern, but also COT is difficult to meet the requirements of heating and humidification in extubated patients. Yu Y, et al. (2017) High-flow nasal cannula (HFNC) can supply a mixture of air and oxygen via a heated and humidified circuit at a very high flow. It can provide almost pure oxygen with a FiO2 of approximately 100% and a maximal flow rate up to 60 L/min. The use of a HFNC may generate a positive airway pressure, ameliorate oxygenation and dyspnea, reduce the respiratory rate and work of breathing, and improve comfort. Yu Y, et al. (2017) Few studies were conducted in the past 5 years; and the effect of HFNC therapy compared to COT in patients after planned extubation remains inconclusive. This study will be done to compare the usage of HFNC as an alternative to the conventional oxygen therapy following extubation for patients undergoing pulmonary resection. Youfeng Zhu, et al. (2019)

Conditions

Pulmonary Resection; Oxygen Therapy

Outcome Measures

Primary Outcomes (1)

• HFNC is superior to conventional oxygen for reducing hypoxemia [arterial partial pressure of oxygen/fraction of inspired oxygen] < 300) and postoperative pulmonary complications occurring within 30 days in extubated patients after lung resection.

  patients were extubated intraoperative, and at the ICU we compared HFNC to standard oxygen therapy. Postoperative pulmonary function expressed as ppoFEV1 (predicted postoperative forced expiratory volume in one second) was prognosticated preoperatively using spirometry. Oxygen therapy was delivered for at least 48 hours, and if any patient needed more time on oxygen therapy; it was maintained and patients were allowed to be transferred from control group to study group if needed, but didn't happen. HFNC oxygen therapy group (HFNCG) received a flow rate of 35 to 60 L/min and FiO2 was titrated (from 45% to 100%) by the treating clinician to maintain a peripheral oxygen saturation (SpO2) of 95% or more. The conventional oxygen therapy group (COG) received oxygen via either nasal prongs or facemask with oxygen flow titrated by the bedside clinician to maintain a SpO2 of 92% or more.

  120 weeks

Study Arms (2)

those that receive the conventional oxygen

EXPERIMENTAL

This study will be conducted on 180 patients who will be undergoing lung resection (wedge resection, segmentectomy, metastasectomy, lobectomy, or pneumonectomy) surgery at the Cardiothoracic department, Ain Shams University Hospitals; patients are to be extubated intraoperative, and at the ICU will be given HFNC . The endpoints of the study are to investigate whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for reducing hypoxemia and postoperative pulmonary complications in extubated patients after lung resection.

Other: Oxygen therapy

those that receive the high flow oxygen therapy.

EXPERIMENTAL

This study will be conducted on 180 patients who will be undergoing lung resection (wedge resection, segmentectomy, metastasectomy, lobectomy, or pneumonectomy) surgery at the Cardiothoracic department, Ain Shams University Hospitals; patients are to be extubated intraoperative, and at the ICU will be given standard oxygen therapy . The endpoints of the study are to investigate whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for reducing hypoxemia and postoperative pulmonary complications in extubated patients after lung resection.

Other: Oxygen therapy

Interventions

Oxygen therapy OTHER

This study will be conducted on 180 patients who will be undergoing lung resection (wedge resection, segmentectomy, metastasectomy, lobectomy, or pneumonectomy) surgery at the Cardiothoracic department, Ain Shams University Hospitals; patients are to be extubated intraoperative, and at the ICU we will be comparing HFNC to standard oxygen therapy. The endpoints of the study are to investigate whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for reducing hypoxemia and postoperative pulmonary complications in extubated patients after lung resection.

Also known as: oxygen

those that receive the conventional oxygen; those that receive the high flow oxygen therapy.

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective lung resection, including lobectomy, wedge resection, segmentectomy, metastasectomy; open thoracotomy or video-assisted thoracoscopic surgery (VATS)

You may not qualify if:

• Age below 10 years and above 80 years, as this age range was the age in the 2 pervious studies in literature.
• Immunocompromised patients.
• Pregnant females.
• Patients with history of obstructive sleep apnea.
• Tracheostomized patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University Hospitals

Cairo, 11511, Egypt

RECRUITING

Related Publications (1)

• Yu Y, Qian X, Liu C, Zhu C. Effect of High-Flow Nasal Cannula versus Conventional Oxygen Therapy for Patients with Thoracoscopic Lobectomy after Extubation. Can Respir J. 2017;2017:7894631. doi: 10.1155/2017/7894631. Epub 2017 Feb 19.

  PMID: 28298878 BACKGROUND

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• ahmed t. hussain kamel, MSC

  ainshams uU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed T. Hussain kamel, MSC

CONTACT

+201227878059; Dr.ath@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: August 23, 2022
• Study Start: January 1, 2019
• Primary Completion: August 20, 2022
• Study Completion: December 1, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

EG (1)