Effectiveness of a perioperative respiratory care protocol in patients scheduled to receive major abdominal surgery

Perioperative Hierarchical respIratory Care for the prevention of respiratory Complications after UPper abdominal surgery: a randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16256069

Enrollment

400

Registered

2018-07-25

Start date

2018-09-15

Completion date

Unknown

Last updated

2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative respiratory complications after abdominal surgery Respiratory Postprocedural pulmonary complications after abdominal surgery

Interventions

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 t

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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)	—

Countries

China

Contacts

Public ContactZhongheng Zhang

zh_zhang1984@zju.edu.cn+8657182552629

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026