Continuous Positive Airway Pressure After Abdominal Surgery

Continuous Positive Airway Pressure After Abdominal Surgery -A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Surgery; Continuous Positive Airway Pressure; Lung Function
• Intervention / Treatment: Device: Auto-CPAP; Device: CPAP since before

Detailed Description

Theory Research question: Does nasal CPAP abolish postoperative hypoxia and lung function decline after abdominal surgery?

Methods This is a randomized controlled trial with an allocation ratio of 1:1. Half of the patients are randomized to CPAP and half to routine medical care. Randomization is generated by a computer program and handled by a person outside the study. Randomization procedure is documented by the contact person and in the patient's study protocol.

Include are one hundred and twenty patients age 18-80 years old, scheduled for abdominal surgery at Umeå university hospital. Excluded are patients with American Society of Anesthesia (ASA) class 2-3 and patients with cognitive impairment or dementia, unable to participate. Patients with ongoing CPAP treatment are not randomized. Instead, they form a separate group with ongoing CPAP after surgery

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.

A need of 35 patients in each arm was estimated to detect a difference in mean (SD) in PaO2 of 1 (1.5) kilo Pascal with a significance of p<0.05 and a power of 80%. Due to dropouts, it is estimated a need to include and randomize 120 patients.

Patients in the CPAP treated group are given an auto-CPAP that can increase the pressure during respiratory arrest (AirSense 10 AutoSet, ResMed Inc) including a silicone nasal mask. It is set with a minimum pressure of 5 cm and a maximum pressure of 10 cm during instruction on the day before surgery. Pressure and mask are tested by trained personnel at the Lung section so that both pressure and mask are comfortable and can be tolerated by the patient. Immediately after surgery they will be given 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 receive standard treatment and supplemental oxygen if oxygen saturation falls below 90%

Included in a third arm are patients who already are using CPAP at night at home for previously diagnosed obstructive sleep apnea. They are instructed to use CPAP for 2 hours immediately after surgery and subsequent nights during hospital stay.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Umea
    • Umeå, Umea, Sweden, 901 85
      • Dept of Surgery, Inst of Surgical and Perioperative sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Regular treatment
EXPERIMENTAL: Auto CPAP; Auto CPAP, AirSense 10 AutoSet, ResMed Inc, max pressure 10 cm water, min pressure 5 cm water	Device: Auto-CPAP; AIrSense 10, Auto-CPAP, Minimum pressure 5 cm water, maximum pressure 10 cm water
OTHER: CPAP since before; 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; A CPAP the patient uses since before because of previously diagnosed obstructive sleep apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial oxygen partial pressure	Difference in PaO2	Difference in change from baseline before surgery to follow-up at postoperative day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffusion capacity for carbon monoxide	Difference in diffusion capacity	Difference in change from baseline before surgery to follow-up at postoperative day 2
Forced vital capacity (FVC)	Difference in FVC	Difference in change from baseline before surgery to follow-up at postoperative day 2
Forced expiratory volume in one second (FEV1)	Difference in FEV1	Difference in change from baseline before surgery to follow-up at postoperative day 2
PaCO2	Difference in PaCO2	Difference in change from baseline before surgery to follow-up at postoperative day 2
time of hypoxia with SaO2 <90%	Time with hypoxia (SaO2 <90%)	During postoperative night 2
Side effects of CPAP	Type of side effects from CPAP	From day of surgery to the second postoperative day
CPAP compliance	Number of hours using CPAP	From day of surgery to the second postoperative day
Sleep apnea	Effect of CPAP with regard to the occurrence of sleep apnea	From day of surgery to the second postoperative day

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Karl A Franklin, Prof, Department of Surgery

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 10, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: February 7, 2021
• First Submitted That Met QC Criteria: February 7, 2021
• First Posted (ACTUAL): February 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-03408

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No