Plain English Summary
Background and study aims
Patients scheduled to have major abdominal surgery are at increased risk of postoperative pulmonary complications (PPCs), as the lung will be mechanically ventilated during anaesthesia, which could lead to collapse and invasion by pathogens. Therefore, it is vital to take measures to prevent PPCs through perioperative respiratory care (care during the time period surrounding and during the operation). This care is not individualized and is the same for all patients. However, PPCs and lung function can differ substantially between patients. Therefore, different perioperative respiratory care should be provided for different patients.
This study aims to test whether using a protocol-based approach to tailor perioperative respiratory care to the patient can reduce the risk of PPCs.
Who can participate?
Patients scheduled to have major upper abdominal surgery
What does the study involve?
Participants are randomised into either the intervention or the control group.
Participants in the control group willy receive the conventional treatment of deep breath and cough direction, where they are asked to take 10 deep breaths followed by 3 coughs.
The intervention group will receive perioperative hierarchical respiratory care, where they receive a score based on their lung function which is then used to determine the best course of treatment for them, with strategies including deep breathing, coughing, positive pressure ventilation and incentive spirometry.
What are the possible benefits and risks of taking part?
The benefit for participants is that by taking part they will receive detailed instructions for perioperative breathing training, and will receive an additional booklet containing these. There are no known risks to participants taking part in this study, as the strategies used in both groups are routinely performed within hospitals.
Where is the study run from?
Sir Run Run Shaw Hospital, Hangzhou, China
When is the study starting and how long is it expected to run for?
April 2018 to December 2019
Who is funding the study?
Sir Run Run Shaw Hospital (China)
Who is the main contact?
Dr Zhongheng Zhang
zh_zhang1984@hotmail.com
Trial website
Contact information
Type
Public
Primary contact
Dr Zhongheng Zhang
ORCID ID
http://orcid.org/0000-0002-2336-5323
Contact details
3#
qingchun east road
Hangzhou
310016
China
+8657182552629
zh_zhang1984@zju.edu.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2018-01
Study information
Scientific title
Perioperative Hierarchical respIratory Care for the prevention of respiratory Complications after UPper abdominal surgery: a randomized controlled study
Acronym
HICCUP
Study hypothesis
Perioperative Hierarchical respiratory care is able to reduce the risk of respiratory complications after upper abdominal surgery
Ethics approval
The study was approved by the ethics committee of Sir Run Run Shaw hospital, 21/05/2018, 20180521-2
Study design
Interventional randomised controlled single-center study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Perioperative respiratory complications after abdominal surgery
Intervention
Participants will be randomly assigned to the intervention and control groups using central randomisation with a computer generated random number.
The control group will only receive the conventional treatment of deep breath and cough direction, where they are asked to take 10 deep breaths followed by 3 coughs.
The intervention group will receive perioperative hierarchical respiratory care, where participants are classified according to pulmonary function and are given a score of 0-10 based on this, which is then used to determine a strategy for bronchial hygiene and lung expansion. Patients are classified using the following criteria:
1. Disease (bronchial hygiene)
2. Lung injury
3. Operation/neuromuscular status
4. Chest imaging
5. Airflow/breath sound
6. Respiratory type/breathing work
7. Effective coughing
8. Activity ability
9. Oxygen therapy level
10. Subextremal exercise test
11. Six minute walk
12. Pulmonary function test
Each criteria receives a score of 0-3 points, where 0 indicates "none", 1 indicates "mild", 2 indicates "moderate" and 3 indicates "severe". The scores are then added up to give a final score. Patients with a final score of 0-2 will receive conventional deep breath and cough direction. Patients with a final score of 3-4 will be given incentive spirometry if deep breath and cough direction cannot improve respiratory function. Patients with 5-6 points will be given positive ventilation. Patients with a score of 7 or high will be given positive ventilation and high flow oxygenation.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Perioperative pulmonary complications, defined by the occurrence of one or more of the following during the hospital stay or within 28 days of discharge (depending on which occurred first):
1. Pneumonia, the presence of radiological evidence of pulmonary infiltration associated with at least 2 of the following criteria:
1.1. Purulent sputum
1.2. Elevated body temperature (38.0 °C)
1.3. Leukocytosis (25% above baseline preoperative value)
2. Tracheobronchitis, a marked increase in sputum production or presence of purulent sputum in a subject with a normal chest x-ray
3. Atelectasis with clinical repercussion or radiological evidence of atelectasis associated with dyspnea
4. Acute respiratory failure or acute deficiency of gas exchange with necessity for invasive or noninvasive mechanical ventilation
5. Bronchoconstriction, the presence of wheezing associated with dyspnea requiring bronchodilator prescription or a change in preoperative bronchodilator dosage
Secondary outcome measures
1. Length of stay in ICU and hospital, measured after 90 days
2. Perioperative mortality, measured after 7 days
3. Cost of the total hospital stay (including cost of surgery and drugs)
Overall trial start date
01/04/2018
Overall trial end date
30/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Awaiting elective upper abdominal surgery that required:
2.1. General anaesthesia
2.2. Minimum 5 day hospital stay
2.3. 5 cm or longer incision above or extending above the umbilicus
3. Attended outpatient pre-admission assessment clinic
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Pregnant
2. Neuromuscular disease
3. Systemic diseases without surgical conditions
4. Cannot cooperate as result of a consciousness disorder
5. Cannot provide informed consent
Recruitment start date
15/09/2018
Recruitment end date
30/06/2019
Locations
Countries of recruitment
China
Trial participating centre
Sir Run Run Shaw hospital
3#, east Qingchun Road
Hangzhou
310016
China
Funders
Funder type
Not defined
Funder name
none
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results will be published in academic journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to local policy for confidentiality of patients
Intention to publish date
06/06/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list