Continuous Positive Airway Pressure After Abdominal Surgery

NCT04747535 | Unknown

• 1 other identifier: 2020-03408
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Arterial oxygen partial pressure

  Difference in PaO2

  Difference in change from baseline before surgery to follow-up at postoperative day 2

Secondary Outcomes (8)

• Diffusion capacity for carbon monoxide

  Difference in change from baseline before surgery to follow-up at postoperative day 2

• Forced vital capacity (FVC)

  Difference in change from baseline before surgery to follow-up at postoperative day 2

• Forced expiratory volume in one second (FEV1)

  Difference in change from baseline before surgery to follow-up at postoperative day 2

• PaCO2

  Difference in change from baseline before surgery to follow-up at postoperative day 2

• time of hypoxia with SaO2 <90%

  During postoperative night 2

Study Arms (3)

Control

NO INTERVENTION

Regular treatment

Auto CPAP

EXPERIMENTAL

Auto CPAP, AirSense 10 AutoSet, ResMed Inc, max pressure 10 cm water, min pressure 5 cm water

Device: Auto-CPAP

CPAP since before

OTHER

Patients with CPAP since before will all continue using CPAP. They will not attend the randomization process. They will be regarded as a separate group.

Device: CPAP since before

Interventions

Auto-CPAP DEVICE

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

Auto CPAP

CPAP since before DEVICE

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

CPAP since before

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age 18-80 years) scheduled for elective abdominal surgery
• Must be able to tolerate nasal CPAP

You may not qualify if:

• American Society Anesthesia (ASA) Class 3-4.
• Cognitive impairment or dementia

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Dept of Surgery, Inst of Surgical and Perioperative sciences

Umeå, Umea, 901 85, Sweden

Location

Study Officials

• Karl A Franklin, Prof

  Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl A Franklin, Prof

CONTACT

+46 706884745; karl.franklin@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 10, 2021
• Study Start: May 10, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 30, 2021

Record last verified: 2021-03

Locations

SE (1)