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Continuous Positive Airway Pressure After Abdominal Surgery

NCT04747535 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-04-30

No results posted yet for this study

Summary

This is a randomized controlled trial with an allocation ratio of 1:1. Half the patients are randomized to continuous positive airway pressure (CPAP) and half to routine medical care. Included are one hundred and twenty patients aged 18-80 years plus patients with ongoing CPAP scheduled for abdominal surgery at Umeå university hospital. The primary outcome is oxygen partial pressure (PaO2) measured on postoperative day 2 compared with the day before surgery. Secondary outcomes include diffusion capacity for carbon-monoxide, vital capacity, FEV1 and carbon-dioxide partial pressure (PaCO2) on postoperative day 2 compared with the day before surgery. PaO2 and PaCO2 are recorded from blood gas measurements obtained from the radial artery. Percentage of nocturnal hypoxia defined as the percentage of oxygen saturation during 90% of the second postoperative night. Tolerance to CPAP measured by the number of hours used CPAP. Side effects related to CPAP. All patients are examined with a simplified sleep apnea examination (Noxturnal T3, Res Med) the night before surgery.

Patients in the CPAP treated group are given an auto-CPAP with a minimum pressure of 5 cm and a maximum pressure of 10 cm. They will be treated with CPAP for at least 2 hours immediately after surgery and during the first two postoperative nights. Oxygen is supplied to CPAP if oxygen saturation falls below 90%. Patients in the control group receives standard treatment and supplemental oxygen if oxygen saturation falls below 90%. In a third arm, we will include patients who already are using CPAP at night at home for previously diagnosed obstructive sleep apnea. are instructed to use CPAP for 2 hours immediately after surgery and subsequent nights during hospital stay.

Conditions

  • Abdominal Surgery
  • Continuous Positive Airway Pressure
  • Lung Function

Interventions

DEVICE

Auto-CPAP

AIrSense 10, Auto-CPAP, Minimum pressure 5 cm water, maximum pressure 10 cm water

DEVICE

CPAP since before

A CPAP the patient uses since before because of previously diagnosed obstructive sleep apnea

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Principal Investigators

  • Karl A Franklin, Prof · Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04747535 on ClinicalTrials.gov