Condition category
Surgery
Date applied
19/06/2014
Date assigned
19/06/2014
Last edited
10/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Klein

ORCID ID

Contact details

Clinical Trials
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
-
andrew.klein@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16802

Study information

Scientific title

The efficacy of prophylactic nasal high flow oxygen compared with standard oxygen therapy in improving early postoperative recovery after lung resection surgery

Acronym

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

NRES Committee East Midlands - Derby, 19/03/2014, ref. 14/EM/0105

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

6-minute walk measured 2 days after surgery

Secondary outcome measures

Not provided at time of registration

Overall trial start date

23/04/2014

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients undergoing elective lung resection surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 64; UK Sample Size: 64

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

United Kingdom

Trial participating centre

Papworth Hospital NHS Foundation Trust
Cambridge
CB23 3RE
United Kingdom

Sponsor information

Organisation

Papworth Hospital NHS Trust (UK)

Sponsor details

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The National Institute of Academic Anaesthesia (NIAA); Grant Codes: WKR0-2013-0062

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26409713

Publication citations

Additional files

Editorial Notes

10/08/2017: Publication reference added.