High flow nasal oxygen after lung resection surgery
| ISRCTN | ISRCTN04561506 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04561506 |
| Secondary identifying numbers | 16802 |
- Submission date
- 19/06/2014
- Registration date
- 19/06/2014
- Last edited
- 10/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Patients who undergo lung resection surgery are at risk of respiratory complications after the operation. One established method of reducing the risk of these complications is to treat patients with non- invasive ventilation (NIV) after the operation. However, this often requires admission to a high dependency unit or intensive care (ICU), and is so is costly and labour intensive. Nasal high flow oxygen in addition to other possible benefits can provide a low level of positive airway pressure similar to NIV, but is easy enough to use that it may be administered on a normal ward. The aim of this study is to find out whether the use of nasal high flow oxygen after lung resection surgery can improve patients early functional outcome and recovery. The 6-minute walking test (6MWT) is used to determine this, because it is a measure of patients functional ability, i.e. it represents how much they can do. It is therefore directly relevant to their recovery. Patients' recovery is also assessed subjectively using a validated recovery questionnaire.
Who can participate?
Adult patients who are scheduled to undergo partial single lung resection.
What does the study involve?
Before the operation, each patient performs a 6MWT and spirometry test under the supervision of a physiotherapist. The 6MWT is an exercise test where patients measure how far they can walk in 6 minutes. Spirometry measures the possible strength of the patients breathing. Patients thereafter undergo their surgery and have anaesthesia as they would normally. After the operation they are treated in accordance with the enhanced recovery program for thoracic surgery already established at the hospital, incorporating adequate pain relief, postoperative physiotherapy, early mobilisation, good nutrition, and appropriate removal of chest drains and tubes. On arrival in the recovery room after their surgery, patients are randomly allocated to receive supplemental oxygen via a soft facemask (standard group), or via high flow nasal cannulae (intervention group). Patients are administered oxygen for at least 24 hours after the operation. Patients who develop breathing difficulties receive treatment as required based on their clinical need. Spirometry is tested daily after the operation. This takes about 5 minutes. On the third day after the operation they repeat the 6MWT. Additionally the x-rays of patients are compared after the operation to see if one group has more areas of lung collapse than the other group. Pain scores and the amounts of painkillers required are also compared. A short questionnaire is used to determine whether there is any difference in how patients feel they recovered, and to evaluate how they tolerated either the facemask or high flow nasal cannulae.
What are the possible benefits and risks of participating?
Benefits include comfortable and improved breathing if treated with high flow oxygen which is heated and humidified, and may speed up and improve recovery from surgery. Risks include some patients may find high flow oxygen uncomfortable when it is started and it will need adjusting. Some patients may get air trapped in the stomach very occasionally, which should get better on its own. No other risks identified up to now.
Where is the study run from?
Papworth Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2014 to May 2015
Who is funding the study?
The National Institute of Academic Anaesthesia (NIAA) (UK)
Who is the main contact?
Dr Andrew Klein
andrew.klein@nhs.net
Contact information
Scientific
Clinical Trials, Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
| andrew.klein@nhs.net |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The efficacy of prophylactic nasal high flow oxygen compared with standard oxygen therapy in improving early postoperative recovery after lung resection surgery |
| Study hypothesis | That the routine administration of nasal high flow oxygen post lung resection surgery leads to improved early functional recovery as determined by a 6-minute walk test, compared with usual care low flow facemask or nasal prongs oxygen therapy. |
| Ethics approval(s) | NRES Committee East Midlands - Derby, 19/03/2014, ref. 14/EM/0105 |
| Condition | Topic: Surgery; Subtopic: Surgery; Disease: All Surgery |
| Intervention | Patients will perform a 6-minute walk test and spirometry before their surgery. In addition, they will complete the Post-operative Quality Recovery Scale (PQRS) recovery questionaire. During their surgery they will be randomised using computer generated sequence by research and development staff not directly involved in the study. Patients will have either high flow nasal oxygen or standard oxygen administered in recovery, for a period of 24 hours initially. Post-operatively, the quality of recovery questionnaire will be completed on days 1, 2, and 7 post-operatively. Spirometry will be repeated on post-operative days 1 and 2, and the 6-minute walk test repeated on day 2. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 6-minute walk measured 2 days after surgery |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 23/04/2014 |
| Overall study end date | 01/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 64; UK Sample Size: 64 |
| Participant inclusion criteria | Adult patients undergoing elective lung resection surgery |
| Participant exclusion criteria | 1. Patients undergoing pneumonectomy 2. Patients who cannot undertake a 6MWT 3. Patients with a contraindication to nasal high flow oxygen 4. Patients who are treated with CPAP pre-operatively |
| Recruitment start date | 23/04/2014 |
| Recruitment end date | 01/05/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CB23 3RE
United Kingdom
Sponsor information
Hospital/treatment centre
Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom
"ROR" |
https://ror.org/01qbebb31 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/08/2017: Publication reference added.
