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OpenTrials
Completed

NCT Number: NCT04877353

Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease

In Qena university hospital a prospective, randomized study was carried out on 100 COPD patients, all were divided into; conventional therapy without NIV (C group) 50 patients or with prophylactic NIV(N group) 50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery . Primary endpoint was the acute respiratory events (ARE) .Secondary endpoints were acute respiratory failure (ARF), intubation rate, mortality rate, infectious and non-infectious complications, and ICU stay.

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Key information

Conditions

Acute Respiratory Failure Post Surgical (Diagnosis) Chronic Disease Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

asmaa Mostafa

Luxor, 85951, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria:
  • Age˃18 years, scheduled for upper abdominal surgery under general anesthesia.
  • Moderate to very severe COPD (GOLD II to IV).
  • ASA functional status II or greater.
  • Exclusion criteria:
  • Contraindications to the application of NIV.
  • Sleep apnea syndrome.
  • Facial deformation.
  • Inability to follow the study.

Treatment and study plan

NIV

Device

NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery

Primary outcomes

  1. acute respiratory events

    Time frame: 28days

    patients %

Secondary outcomes

  1. acute respiratory failure

    Time frame: 28 days

    patients %

  2. intubation rate

    Time frame: 28 days

    patients %

  3. ICU mortality

    Time frame: 28 days

    patients %

  4. ICU length of stay

    Time frame: 28 days

    days

  5. infectious and non infectious complications

    Time frame: 28 days

    patients %

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 7, 2021
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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