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High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy

NCT ID: NCT02544477

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-09-30

Brief Summary

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The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia

Detailed Description

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High-flow nasal cannula oxygen (HFNCO) treatment has been showed to have several clinical advantages compared with conventional oxygen therapy. Currently, no reports have described the effects of HFNCO in postoperative patients after thoracic surgery. The primary objective of this study is to determine the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio \<300) in patients with lung cancer after pulmonary lobectomy.

In the postoperative period after extubation, patients will be randomly assigned to either:

1. standard oxygen therapy group (control group) or
2. HFNCO group (study group).

In the control group, patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. Patients in the study group will be given HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. After 48 hours from study entry, all patients will be evaluated for possible interruption of oxygen treatment on the basis of their clinical conditions.

Conditions

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Respiratory Insufficiency Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-flow nasal cannula oxygen (HFNCO)

Patients will receive HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%.

Group Type EXPERIMENTAL

High-flow Nasal Cannula Oxygen (HFNCO)

Intervention Type DEVICE

standard oxygen therapy

Patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%.

Group Type ACTIVE_COMPARATOR

Conventional oxygen treatment

Intervention Type DEVICE

Interventions

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High-flow Nasal Cannula Oxygen (HFNCO)

Intervention Type DEVICE

Conventional oxygen treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* planned pulmonary lobectomy for lung cancer

Exclusion Criteria

* age \<18 years
* patient refusal
* body mass index ≥35 kg/m2
* sleep apnea syndrome
* tracheostomy
* home oxygen therapy
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Maria Teresa Congedo

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Universitario Agostino Gemelli

Rome, , Italy

Site Status

Countries

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Italy

References

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Pennisi MA, Bello G, Congedo MT, Montini L, Nachira D, Ferretti GM, Meacci E, Gualtieri E, De Pascale G, Grieco DL, Margaritora S, Antonelli M. Early nasal high-flow versus Venturi mask oxygen therapy after lung resection: a randomized trial. Crit Care. 2019 Feb 28;23(1):68. doi: 10.1186/s13054-019-2361-5.

Reference Type DERIVED
PMID: 30819227 (View on PubMed)

Other Identifiers

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HFNC after pulmonary lobectomy

Identifier Type: -

Identifier Source: org_study_id